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- Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular (also known as Shangai Chaojimengnan)
- Audience: Consumers, healthcare professionals
[Posted 12/31/2007] FDA notified consumers and healthcare professionals not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan) products. The products are marketed as dietary supplements and used for the treatment of erectile dysfunction (ED) and for sexual enhancement. The products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for ED. The products are thus drugs that are illegal because they lack FDA approval. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of the ingredients can not be validated.
The undeclared ingredients in the referenced products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have these products should discontinue using them and consult their healthcare professional.
[December 28, 2007 - News Release - FDA]
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- Bayer Diabetes Care Contour Test Strips (TS)
- Audience: Endocrinologists, healthcare professionals, diabetic patients, and pharmacies
[Posted 12/26/2007] Bayer Diabetes Care notified healthcare professionals and consumers of a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. The product was recalled because test strips from specific lots could result in blood glucose readings with a positive bias that could demonstrate 5 - 17% higher test results. This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter. There is no impact on the performance of strips with other Bayer meters.
Healthcare professionals, retailers, patients and other customers who use Contour TS are advised to check the lot number of the test strips in their inventory and contact Bayer Diabetes Care for information regarding the return and replacement of strips. See the manufacturer's press release for specific product lot numbers affected by this recall.
[December 21, 2007 - Press Release - Bayer Diabetes Care]
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- Cardinal Health Alaris Pump Module
- Audience: Hospital administrations, hospital risk managers, healthcare professionals
[UPDATE 01/11/2008] FDA informed healthcare professionals that the recall of all Alaris Infusion Pump modules (formerly Medley) shipped prior to September 27, 2007, has been classified as a Class I Recall.
[Posted 12/26/2007] Cardinal Health notified its customers of a voluntary recall for all Alaris Pump modules, model 8100 (formerly known as Medley Pump module), shipped prior to September 27, 2007. The recall covers Alaris Pump modules that were distributed to 46 States, the District of Columbia, Canada, Guam, Puerto Rico and Saudi Arabia. The pump module was recalled because the units may contain misassembled occluder springs (bent, broken, nested or missing) that occurred during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion. See the manufacturer's press release for a list of the serial numbers for the affected devices and how the manufacturer will work with customers to minimize disruption while completing an inspection of the devices.
[January 11, 2008 - Recall Notice - FDA]
[December 26, 2007 - Press Release - Cardinal Health]
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- Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes)
- Audience: Hospital and nursing home administrators, hospital risk managers, pharmacists, other healthcare professionals, consumers
[Posted 12/21/2007] AM2 PAT, Inc., and FDA informed healthcare professionals and consumers of a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution (5 ml in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes were found to be contaminated with Serratia marcescens, which have resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. Consumers and user facilities should immediately stop using the product, quarantine it and return the affected product to the distributor.
[December 20, 2007 - Press Release - AM2 PAT, Inc]
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- Fentanyl Transdermal System (marketed as Duragesic and generics)
- Audience: Pain management specialists, other healthcare professionals
[Posted 12/21/2007] FDA issued an update that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch). FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and safe use of the transdermal system. However, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.
Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose.
[December 21, 2007 - Public Health Advisory - FDA]
[December 21, 2007 - Information for Healthcare Professionals - FDA]
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- Nonoxynol 9 (N9) OTC Contraceptive Products
- Audience: Consumers, healthcare professionals
[Posted 12/18/2007] FDA issued a final rule that requires that manufacturers of over-the-counter stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9 does not provide protection against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs). Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. Additionally, the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner. Consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly.
[December 18, 2007 - News Release - FDA]
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- PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]
- Audience: Pediatricians, family practitioners, other health professionals, consumers
[Posted 12/14/2007] Merck & Co. and FDA informed healthcare professionals and consumers of a voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines. The vaccines were recalled because the manufacturer cannot assure sterility of the affected lots. Routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB and COMVAX identified the presence of Bacillus cereus bacteria. Sterility tests of the vaccine lots themselves have not found any contamination. The affected doses were distributed in the U.S. starting in April 2007. Healthcare professionals should immediately discontinue use of any of the affected lots and follow the manufacturer's instructions for returning recalled vaccines. See the FDA Consumer Update for a list of the specific lots of each vaccine recalled.
[December 13, 2007 - FDA Consumer Update - FDA]
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- Electric Dental Handpieces
- Audience: Dentists, Oral Surgeons, dental hygienists, other healthcare professionals
[Posted 12/13/2007] FDA informed healthcare professionals about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage occurred, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns occurred during the cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating can also occur during any dental procedure. This problem is not limited to dentistry. Rotary surgical handpieces can cause patient burns during orthopedic procedures, as reported in the July 2003 edition of FDA Patient Safety News (http://www.fda.gov/cdrh/psn/show17-burns.html). Read the FDA Public Health Notification for specific actions to prevent or minimize serious patient injuries associated with using electric dental handpieces.
[December 12, 2007 - Public Health Notification - FDA]
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- Radio Frequency Ablation Devices
- Audience: Thoracic Surgeons, hospital administrators, other healthcare professionals
[Posted 12/12/2007] FDA alerted healthcare professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation. Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities. While RF ablation devices have been cleared for general indications- ablation of soft tissue by thermal coagulation necrosis- the devices have not been cleared specifically for lung tumor ablation. Healthcare professionals should use caution when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, Operators Manual, the Manufacturer's Instructions for Use and any training provided. Additionally, if healthcare professionals plan to use RF ablation devices to treat patients with lung tumors, they should consider enrolling patients in an approved clinical study, where training is available.
[December 11, 2007 - Public Health Notification - FDA]
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- Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics)
- Audience: Neurologists, psychiatrists, other healthcare professionals, consumers
[Posted 12/12/2007] FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive for HLA-B*1502.
[December 12, 2007 - Information for Healthcare Professionals - FDA]
[December 12, 2007 - Drug Information Page - FDA]
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- Vail Products Enclosed Bed Systems
- Audience: Hospital and Extended Care Facility Administrators, Risk Managers, consumers
[Posted 12/04/2007] FDA provided final recommendations for users of Vail Enclosed Bed Systems that updates the Agency's 2005 Preliminary Public Health Notification. Users of the bed systems were warned that the bed poses a health risk because patients can become entrapped in them and suffocate. Because of the suffocation risk, FDA advises hospitals, nursing homes and consumers who have a Vail enclosed bed system to stop using it and move the patient to an alternate bed. Consumers who are using Vail beds at home should consult with their physicians about other options. See the Public Health Notification for safety precautions recommended by the manufacturer if continued use of the Vail bed is the only option.
[December 04, 2007 - Public Health Notification - FDA]
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- Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)
- Audience: Endocrinologists, pediatricians, other healthcare professionals
[UPDATE 8/07/2008] The Dear Healthcare Professional Letter issued by Sanofi-aventis U.S. in December 2007 has been added as a link below. Also, links to prescribing information for healthcare professionals and patient package labeling with the safety-related revisions highlighted are included for the following DDAVP (desmopressin acetate) Sanofi-aventis, U.S. products: Nasal Spray, Rhinal Tube, Injection, and Tablets.
[Posted 12/04/2007] FDA notified healthcare professionals and patients of the Agency's request that manufacturers update the prescribing information for desmopressin to include important new safety information about severe hyponatremia and seizures. Certain patients, including children treated with the intranasal formulation of the drug for primary nocturnal enuresis (PNE), are at risk for developing severe hyponatremia that can result in seizures and death. As such, desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or patients with a history of hyponatremia. PNE treatment with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.
[December 04, 2007 - Information for Healthcare Professionals - FDA]
[December 2007 - Dear Healthcare Professional Letter - Sanofi-Aventis] 
[October 2007 - DDAVP Injection - Label - Sanofi-Aventis]
[October 2007 - DDAVP Nasal Spray - Label and PPI - Sanofi-Aventis]
[October 2007 - DDAVP Rhinal Tube - Label and PPI - Sanofi-Aventis]
[October 2007 - DDAVP Tablets - Label - Sanofi-Aventis]
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- Myfortic (mycophenolic acid) Delayed-Release Tablets
- Audience: Oncologists, OB/GYN physicians, other healthcare professionals, patients
[Posted 11/27/2007] Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration.
A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Female patients of childbearing potential must receive contraceptive counseling and must use effective contraception while taking Myfortic. Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.
[November 2007 - Dear Healthcare Professional letter - Novartis]
[October 2007 - Label - Novartis]
Previous MedWatch Alert:
[10/29/2007]
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- Encore Supplement Tablets
- Audience: Healthcare professionals, consumers
[Posted 11/26/2007] Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of Encore Tablets, a dietary supplement sold in health food stores, via the internet and by mail order nationwide and in Canada. The product was recalled because it contains potentially harmful, undeclared ingredients. One lot of the product contained aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction. The undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have this product should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
[November 21, 2007 - Press Release - Bodee LLC]
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- Chantix (varenicline)
- Audience: Healthcare professionals, consumers
[UPDATE 05/16/2008] FDA informed healthcare professionals and patients that as the Agency’s review of Chantix safety data has progressed, it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms. Prescribing information for Chantix was revised to include this safety information in the WARNINGS and PRECAUTIONS sections of the label, and a Medication Guide for patients is also available. If patients, their families, or caregivers notice agitation, depressed mood, or changes in behavior that are not typical for the patient or if the patient has suicidal thoughts or actions, the patient should stop taking Chantix and contact their healthcare professional.
[Posted 11/20/2007] FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
[May 2008 - Label - Pfizer]
[May 16, 2008 - Drug Information Page - FDA]
[May 16, 2008 - Medication Guide - Pfizer]
[May 16, 2008 - Information for Healthcare Professionals sheet - FDA]
[November 20, 2007 - Ongoing Safety Review: Varenicline (marketed as Chantix) - FDA]
[November 2007 - Prescribing Information - Pfizer]
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- Age Intervention Eyelash
- Audience: Ophthalmologists, dermatologists, estheticians, consumers
[Posted 11/19/2007] FDA informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, sold and distributed by Jan Marini Skin Research, Inc. of San Jose, California. The product was seized because it may lead to decreased vision in some users. The eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). Use of the prescription drug in addition to the eyelash product containing the drug, may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to deceased vision and possibly blindness. Other possible adverse events may include macular edema (swelling of the retina) and uveitis (inflammation in the eye) which may lead to decreased vision.
Dermatologists, estheticians, and consumers who may still have Age Intervention Eyelash should discontinue use and discard any remaining product. Consumers should also consult their healthcare professional if they have experienced any adverse events that they suspect are related to use of the product.
[November 16, 2007 - News Release - FDA]
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- Thoratec Implantable Ventricular Assist Devices
- Audience: Cardiologists, hospital risk managers, patients
[Posted 11/16/2007] Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Implantable Ventricular Assist Devices (IVADs), serial numbers 488 and higher (located on the label of the sterile package and on the driveline’s Y-connector), manufactured and distributed from October 1, 2004 through October 22, 2007. The device is a mechanical air-driven (pneumatic) pump that helps a person's heart that is too weak to pump blood through the body. The current instructions for use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline that could result in not enough blood flow to and from the heart. This recall does not affect implanted IVADs. Physicians should contact their patients if any Thoratec IVAD was placed in the external position and patients should contact their physicians with any questions.
[November 16, 2007 - Recall Notice - FDA]
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- Avandia (rosiglitazone maleate) Tablets
- Audience: Cardiologists, endocrinologists, other healthcare professionals, consumers
[UPDATE 11/19/2007] Information for Healthcare Professionals Sheet highlights changes to the prescribing information for rosiglitazone, including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the product's prescribing information about the potential increased risk of myocardial ischemia.
[Posted 11/14/2007] FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.
[November 19, 2007 - Information for Healthcare Professionals - FDA]
[November 14, 2007 - News Release - FDA]
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- Cefepime (marketed as Maxipime)
- Audience: Healthcare professionals
[UPDATE 05/14/2008] FDA is continuing its investigation of a possible association between the use of cefepime and an increased risk of mortality compared with similar drugs. FDA will communicate its conclusions and any resulting recommendations to the public at the completion of its review.
[Posted 11/14/2007] FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the product's prescribing information and the new information from this meta-analysis.
[May 14, 2008 - Update of Safety Review - FDA]
[November 14, 2007 - Ongoing Safety Review: Cefepime - FDA]
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- Erythropoiesis Stimulating Agents:
Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
- Audience: Oncologists, nephrologists, other healthcare professionals
[UPDATE 01/03/2008] FDA informed healthcare professionals of findings from two additional clinical studies, Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE), and the National Cancer Institute Gynecologic Oncology Group (COG-19), showing an increase in mortality and shorter time to tumor progression in patients with cancer receiving an Erythropoiesis-Stimulating Agent (ESA). Both the PREPARE study in breast cancer and the COG-19 study in cervical cancer showed higher rates of death and or tumor progression in patients who received an ESA compared to patients who did not receive an ESA. FDA strongly recommends that healthcare professionals discuss the risks of ESA-associated tumor progression and shortened survival in patients with cancer before starting or continuing ESA therapy.
[Posted 11/08/2007] FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer and patients with chronic kidney failure. For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater. For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk of death and other serious conditions. The new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.
Additionally, the new boxed warnings clarify that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Further, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.
[January 03, 2008 - Communication about an Ongoing Safety Review - FDA]
[November 08, 2007 - Labels for Epogen, Procit - FDA]
[November 08, 2007 - Label for Aranesp - FDA]
[November 08, 2007 - Drug Information Page - FDA]
Previous MedWatch Alerts:
[February 16, 2007]
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- Trasylol (aprotinin injection)
- Audience: Cardiac surgeons and other healthcare professionals
[UPDATE 05/14/2008] Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
[Posted 11/05/2007] FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
[May 14, 2008 - Drug Information Page - FDA]
[May 14, 2008 - FDA News - FDA]
[November 5, 2007 - FDA News - FDA]
Previous MedWatch Alert:
[October 25, 2007]
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- Welch Allyn AED 10 Automatic External Defibrillators
- Audience: Emergency services personnel, risk managers, and consumers
[UPDATE 11/28/2007] Recall expanded to include Welch Allyn AED 10™ Automatic External Defibrillators, manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970309E, 970310E, and 970311E.
[Posted 11/05/2007] FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.
There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient’s ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.
[November 02, 2007 - Recall Notice - FDA]
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- Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment
- Audience: Hospital Administrators, risk managers, other healthcare professionals
[Posted 11/01/2007] FDA, Centers for Disease Control and Prevention, Environmental Protection Agency, and the Occupational Safety and Health Administration issued a Public Health Notification, "Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment". The notification describes the hazards of using excess cleaning and disinfecting liquids on certain electronic medical equipment and recommends ways to avoid these hazards. The problems included equipment fires and other damage, equipment malfunctions, and healthcare worker burns. Refer to the link below for recommendations on how to avoid hazards and appropriate equipment management.
[November 01, 2007 - Public Health Notification - FDA]
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- NC Solution (antifungal product)
- Audience: Healthcare professionals, consumers
[Posted 11/01/2007] FDA notified healthcare professionals of the seizure of more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements, and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo. NC Solution is considered a drug because it is intended for use in the diagnosis, cure, or treatment of disease in people or animals and is not generally recognized as safe and effective for its intended uses. The company does not have FDA approval for NC Solution.
Consumers who have any products manufactured by General Therapeutics, including NC Solution, should consult their healthcare provider about discontinuing their use and report if they have experienced any adverse events that they suspect are related to the use of these products.
[November 01, 2007 - News Release - FDA]
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- CellCept (mycophenolate mofetil)
- Audience: Cardiac, renal, hepatic transplantation specialists, gynecologists, obstetricians, and other healthcare professionals
[UPDATE 11/27/2007] Prescribing information for Mycophenolic Acid (marketed as Myfortic Delayed Released Tablets) revised to include information that use of drug during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. See the MedWatch alert for Myfortic (mycophenolic acid).
[Posted 10/29/2007] Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Labeling changes include the following sections: BOXED WARNING, WARNINGS/Pregnancy and Pregnancy Exposure Prevention, PRECAUTIONS/Information for Patients, and ADVERSE REACTIONS/Postmarketing Experience.
Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test. In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception. Healthcare professionals and patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. See the Dear Healthcare Professional Letter for additional recommendations for women of childbearing potential.
[October 2007 - Myfortic Label - Novartis]
[October 2007 - Letter - Roche]
[September 2007 - Label - Roche]
Previous MedWatch Alert:
[February 22, 2007]
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- Aprotinin Injection (marketed as Trasylol)
- Audience: Cardiac surgeons, other healthcare professionals
[Posted 10/25/2007] FDA informed healthcare professionals of the Data Safety Monitoring Board's recommendation to stop patient enrollment in the aprotinin treatment group arm of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding in association with cardiac surgery. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.
FDA anticipates re-evaluation of the overall risks and benefits of Trasylol which may result in the need to revise the prescribing information or other regulatory actions. Healthcare professionals who are considering use of Trasylol should be aware of the risks and benefits described in the prescribing information for Trasylol and the accumulating data suggesting Trasylol administration increases the risk of death compared to other antifibrinolytic drugs.
[October 25, 2007 - Early Communication - FDA]
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-
- Provigil (modafinil) Tablets
- Audience: Neuropsychiatric specialists, other healthcare professionals, consumers
[Posted 10/24/2007] FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for Provigil (modafinil). Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The revised labeling updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms. Rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide postmarketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.
Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.
Additional labeling revisions were made to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and PATIENT PACKAGE INSERT sections. See revised labeling below.
[September 2007 - Dear Healthcare Professional Letter - Cephalon]
[August 2007 - Label - Cephalon]
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- Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Revatio (sildenafil)
- Audience: Urologists, other healthcare professionals, consumers
[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra, Levitra, Cialis for the treatment of erectile dysfunction, and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.
[October 18, 2007 - Viagra Information page - FDA]
[October 18, 2007 - Viagra label - Pfizer]
[October 18, 2007 - Cialis Information page - FDA]
[October 18, 2007 - Cialis label - FDA]
[October 18, 2007 - Levitra Information page - FDA]
[October 18, 2007 - Levitra label - FDA]
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-
- Byetta (exenatide)
- Audience: Endocrinologists, other healthcare professionals, consumers
[UPDATED 08/18/2008] Since issuing Information
for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing
pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous
injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic
or necrotizing pancreatitis, all patients required hospitalization, two
patients died and four patients were recovering at time of reporting. Byetta
was discontinued in all 6 cases. Byetta and other potentially suspect drugs should be promptly discontinued
if pancreatitis is suspected. There are no signs or symptoms that distinguish
acute hemorrhagic or necrotizing pancreatitis associated with Byetta from
the less severe form of pancreatitis. If pancreatitis is confirmed, initiate
appropriate treatment and carefully monitor the patient until recovery.
Byetta should not be restarted. Consider antidiabetic therapies other than
Byetta in patients with a history of pancreatitis.
[UPDATED 02/27/2008] Dear Healthcare Professional letter posted.
[Posted 10/16/2007] FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.
Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.
[January, 2008 - Label - Amylin
Pharmaceuticals, Inc.]
[October 16, 2007 - Information for Healthcare Professionals - FDA]
[October, 2007 - Letter - Amylin Pharmaceuticals, Inc. and Eli Lilly and Company]
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-
- Medtronic Sprint Fidelis Defibrillator Leads
- Audience: Cardiologists, emergency services personnel, risk managers, consumers
[UPDATED 10/17/2007] FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Patients who are implanted with this lead, or do not know the model of their lead, should contact their physicians for further information.
[Posted 10/16/2007] FDA issued a statement announcing Medtronic's decision to voluntarily suspend distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company.
When a defibrillator lead is slightly more prone to fracture, most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
[October 17, 2007 - Recall Notice - FDA]
[October 15, 2007 - FDA Statement - FDA]
[October 15, 2007 - Consumer Q&As - FDA]
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-
- Charantea Ampalaya Capsules and Charantea Ampalaya Tea by FullLife Natural Options, Inc.
- Audience: Consumers, healthcare professionals
[Posted 10/15/2007] U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options, Inc., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea. Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension. These claims are evident in the products’ labeling, including promotional literature and FulLife’s Internet Web site.
FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products’ labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. This action protects consumers who may rely on unapproved products and unsubstantiated claims associated with these products when making important decisions about their health.
[October 12, 2007 - Press Release - FDA]
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-
- Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
- Audience: Radiologists, radiology technicians, cardiologists, other healthcare professionals
[Posted 10/12/2007] FDA has received reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography. Four of the 11 reported deaths were caused by cardiac arrest occurring either during infusion or within 30 minutes following the administration of the contrast agent; most of the serious but non-fatal reactions also occurred in this time frame. As a result, the manufacturers of Definity and Optison have agreed to revise the labeling for these products in order to optimize their safe use.
Revised labeling includes changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and a statement in the INDICATIONS section cautioning that the safety and efficacy of the use of Definity with exercise or pharmacological stress testing have not been established. Together these labeling changes emphasize the risk for serious cardiopulmonary reactions, and that the use of these products is contraindicated in patients with unstable cardiopulmonary status, including patients with unstable angina, acute myocardial infarction, respiratory failure, or recent worsening congestive heart failure.
[October 12, 2007 - Drug Information Page - FDA]
[October 12, 2007 - Information for Healthcare Professionals - FDA]
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-
- Cochlear Implants
- Audience: ENT specialists, pediatricians, infectious disease specialists, other healthcare professionals, consumers
[Posted 10/10/2007] FDA informed healthcare professionals and consumers that the Cochlear Implant device used in profoundly deaf or severely hard-of hearing patients has been associated with some increased risk of bacterial meningitis caused by Streptococcus pneumoniae. Children implanted with Cochlear Implants with a positioner component are at a greater risk. There were two cases of deaths from meningitis within the past year in children, ages 9 and 11, implanted with cochlear implants with positioners. Neither child was fully vaccinated, and one died because of the lack of vaccination.
FDA reminds healthcare professionals and consumers that recipients of this device must be fully immunized according to the Center for Disease (CDC) vaccination recommendations. Because children with Cochlear Implants are at increased risk for pneumococcal meningitis, CDC recommends that they receive pneumococcal vaccination under the same schedules that apply to other individuals at high risk for invasive pneumococcal disease.
[October 10, 2007 - Public Health Notification - FDA]
[October 10, 2007 - Advice for Patients - FDA]
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-
- Bisphosphonates marketed as Alendronate
(Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)
- Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals, consumers
[Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.
FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.
Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.
[October 2007 - Early Communication - FDA]
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-
- Hydrocodone in Unapproved Prescription Products
- Audience: Healthcare professionals, pediatricians, consumers
[Posted 09/28/2007] FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a cough suppressant and to treat pain. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.
The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency is particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products. No hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age.
Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007, and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.
There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. Consumers should consult a healthcare professional for detailed guidance on treatment options.
[September 28, 2007 - News Release - FDA]
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-
- Baxa Corporation Exacta-Mix 2400 Operating Software Version 1.07 Pharmacy Compound System
- Audience: Compounding pharmacies, hospitals, other healthcare professionals
[Posted 09/27/2007] Baxa Corporation and FDA informed healthcare professionals of a class I recall of Exacta-Mix 2400 Operating Software Version 1.07, Model No. 8300-0073, Pharmacy Compound System. The device is a compounding system that can be used in pharmacies to add and mix various ingredients into one intravenous (IV) solution.
The device is being recalled because a software failure allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be life-threatening, particularly in newborns.
FDA advises healthcare professionals to stop using this product and contact the manufacturer for a replacement.
[September 27, 2007 - Recall Notice - FDA]
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-
- Axcil and Desirin (marketed as dietary supplements)
- Audience: Consumers, healthcare professionals
[Posted 09/21/2007] TWC Global LLC, Inc., issued a nationwide recall of Axcil and Desirin, both marketed as dietary supplements, because they contain potentially harmful, undeclared ingredients. FDA laboratory analysis of Axcil and Desirin found that the lot of 02B07 contained 3mg/g of sildenafil, the active ingredient of a FDA approved drug used for Erectile Dysfunction (ED). The products also contained sulfosildenafil and sulfohomosildenafil, which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance. Consumers who have these products should stop using them immediately and consult their healthcare professional if they experience any problems that may be due to these products.
[September 20, 2007 - Recall Notice - FDA]
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-
- Baby's Bliss Gripe Water, Apple flavor
- Audience: Consumers, caregivers, pediatricians, other healthcare providers
[Posted 09/21/2007] MOM Enterprises Inc., and FDA informed consumers and healthcare providers that Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled due to the presence of Cryptosporidium infection. The product is labeled Baby's Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething in infants and children.
FDA is investigating the illness of a 6-week old infant who consumed the product. The most common symptom of Cryptosporidium infection is watery diarrhea. Other symptoms include dehydration, weight loss, stomach cramps or pain, fever, nausea, and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. The infection could be life-threatening for certain individuals, including infants, children, and individuals with weakened immune systems.
FDA advises parents/caregivers of children who have recently consumed Baby's Bliss Gripe Water, apple flavor, and have these symptoms to seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection. FDA advises consumers to stop using this product and throw away bottles of the product immediately.
[September 20, 2007 - News Release - FDA]
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- MRL/Welch Allyn AED 20 Automatic External Defibrillators
- Audience: Emergency Services personnel and risk managers
[Posted 09/18/2007] FDA issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer for a replacement.
[September 18, 2007 - Recall Notice - FDA]
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- Haloperidol (marketed as Haldol, Haldol decanoate, and Haldol lactate)
- Audience: Neuropsychiatric and cardiovascular specialists, other healthcare professionals
[Posted 09/17/2007] Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.
There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.
[September 17, 2007 - Healthcare Professional Sheet - FDA]
[August 2007 - Haldol label - Johnson and Johnson]
[August 2007 - Haldol Decanoate label - Johnson and Johnson]
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-
- B. Braun Medical Inc. Normal Saline Flush Syringes
- Audience: Healthcare providers, hospital risk managers, patients
[Posted 09/14/2007] B. Braun Medical Inc., issued a recall of Normal Saline Flush Syringes with lot numbers ending in "SFR" due to an increase in customer complaints of particulate matter in the saline. The introduction of particular matter into the blood stream may result in phlebitis and/or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is also a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause sever injury and/or death. To date, B. Braun has received no reports of any patient injury associated with this issue.
Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to the usage of this product.
[September 14, 2007 - Recall Notice - B. Braun Medical Inc.]
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-
- Fentora (fentanyl buccal tablet)
- Audience: Pain management specialists, other healthcare professionals
[UPDATED 09/26/2007] FDA issued a Public Health Advisory and a Healthcare Professional Sheet to alert healthcare professionals and consumers regarding concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events. The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.
FDA warned physicians and other healthcare professionals that it is critical to follow product labeling when administering Fentora. FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.
Patients also must be under a doctor’s care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately.
In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose.
[Posted 09/13/2007] Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.
[September 26, 2007 - Public Health Advisory - FDA]
[September 26, 2007 - Healthcare Information Sheet - FDA]
[September 10, 2007 - Dear Doctor Letter - Cephalon]
[September 10, 2007 - Dear Healthcare Professional Letter - Cephalon]
[March 2007 - Label with Medication Guide - Cephalon]
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- Abbott Blood Glucose Meters
- Audience: Diabetic patients, endocrinologists, diabetic educators, other healthcare professionals
[Posted 09/11/2007] Abbott notified users of Precision Xtra, Optium, ReliOn Ultima, Rite Aid, and Kroger blood glucose meters (manufactured after January 31, 2007), to check display screen of the meter to make sure that it is working properly. If meters are dropped onto a hard surface, part of the display can be jarred or disconnected, thereby making it difficult to read the lot number or date information. Additionally, dropping the meter can cause the screen to appear blank, which could result in an inability to view blood glucose test results. The inability to generate blood glucose results may cause a significant risk for hypoglycemia or hyperglycemia.
Users of these meters who note that the display screen is not working properly should immediately stop using their meter. Patients should keep their glucose meters in the wallet provided to offer additional protection for the meter. If the meter is dropped on a hard surface, patients should immediately perform a meter display check. Instructions on how to do this are detailed in the meter’s Users Guide. If no problems are encountered during the automatic display check, the meter is ready for use.
[August 31, 2007 - Press Release - Abbott]
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- Viracept (nelfinavir mesylate)
- Audience: Infectious disease specialists, pediatricians, pharmacists, other healthcare professionals
[Posted 09/10/2007] Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the use of Viracept in pregnant women and pediatric patients. EMS is a potential human carcinogen. Data from animal studies indicate EMS is teratogenic, mutagenic and carcinogenic; however, no data from humans exist. FDA has asked Pfizer to implement new specifications to limit the presence of EMS in Pfizer-manufactured Viracept products marked in the United States.
For pediatric patients who are stable on Viracept-containing regimens, FDA and Pfizer agree that the benefit-risk ratio remains favorable and those patients may continue to receive Viracept. Pediatric patients who need to begin HIV treatment should not start regimens containing Viracept until further notice. Pregnant women who need to begin antiretroviral therapy should not be offered regimens containing Viracept until further notice. As a precautionary measure, pregnant women currently receiving Viracept should be switched to an alternative antiretroviral therapy while Pfizer and FDA work to implement the long term EMS specification for Viracept. For pregnant women with no alternative treatment options, FDA and Pfizer agree that the risk-benefit ratio remains favorable for the continued use of Viracept.
[September 10, 2007 - Dear Healthcare Professional Letter - Pfizer]
[September 10, 2007 - Drug Information Page - FDA]
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- Zencore Tabs
- Audience: Consumers, healthcare professionals
[Posted 09/07/2007] Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients. FDA laboratory analysis of Zencore Tabs found that the product contains aminotadalafil, an analog of tadalafil, and sildenafil, both of which are active ingredients of FDA-approved drugs used for Erectile Dysfunction. The product also contained sulfosildenafil and sulfohomosildenafil which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have this product should stop using it immediately and consult their healthcare professional if they experience any problems that may be due to this product.
[August 31, 2007 - Press Release - Bodee LLC, Inc.]
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- METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules
- Audience: Consumers, healthcare professionals
[Posted 08/21/2007] Confidence Inc. informed consumers and healthcare professionals that the company is recalling one lot of METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules (Lot: 3001006, Exp. 10/2009) because the product contains the undeclared drug ingredient sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. The FDA has not approved METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules as a drug, therefore the safety and effectiveness of this product is unknown.
The use of sibutramine may pose a threat to consumers because it is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers should return any unused product to the manufacturer.
[August 17, 2007 - Press Release - Confidence Inc.]
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- Codeine Products Used By Nursing Mothers
- Audience: Obstetricians, pediatricians, other healthcare professionals, consumers
[Posted 08/17/2007] FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person’s genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.
When prescribing codeine-containing drugs to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs. There is an FDA cleared test for determining a patient’s CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events.
[August 17, 2007 - Public Health Advisory - FDA]
[August 17, 2007 - Drug Information Page - FDA]
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- Warfarin (marketed as Coumadin)
- Audience: Hematologists, other healthcare providers, consumers
[Posted 08/16/2007] FDA approved updated labeling to include pharmacogenomics information to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for the widely used blood-thinning drug, Coumadin. This new information explains that people's genetic makeup may influence how they respond to the drug. Specifically, people with variations in two genes may need lower warfarin doses than people without these genetic variations. The two genes are called CYP2C9 and VKORC1. The CYP2C9 gene is involved in the breakdown (metabolism) of warfarin and the VKORC1 gene helps regulate the ability of warfarin to prevent blood from clotting.
The dosage and administration of warfarin must be individualized for each patient according to the particular patient's prothrombin time (PT) / International Normalized Ratio (INR) response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.
[August 16, 2007 - Drug Information Page - FDA]
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- Nonprescription Cough and Cold Medicine Use in Children
- Audience: Parents and caregivers of children receiving cough and cold products, pediatricians, other healthcare providers
[Posted August 15, 2007] FDA announced that on October 18 - 19, 2007, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.
Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label. The Public Health Advisory offers parents and caregivers of children recommendations when using cough and cold products in children.
[August 15, 2007 - Public Health Advisory - FDA]
[August 15, 2007 - Federal Register Meeting Notice - FDA]
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- Avandia (rosiglitazone maleate) Tablets
Actos (pioglitazone hydrochloride) Tablets
Avandaryl (rosiglitazone maleate and glimepiride) Tablets
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets
Duetact (pioglitazone hydrochloride and glimepride) Tablets
- Audience: Endocrinologists, other healthcare professionals, consumers
[UPDATE 11/19/2007] Information for Healthcare Professionals Sheet highlights changes to the prescribing information for rosiglitazone, including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the product's prescribing information about the potential increased risk of myocardial ischemia.
[Posted 08/14/2007] After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning.
The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments.
[November 19, 2007 - Information for Healthcare Professionals - FDA]
[August 14, 2007 - Press Release - FDA]
[August 14, 2007 - Rosiglitazone maleate - Information for Healthcare Professionals - FDA]
[August 14, 2007 - Pioglitazone HCl - Information for Healthcare Professionals - FDA]
Previous MedWatch Alerts: [May 21, 2007]
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- Kaletra (lopinavir/ritonavir) Oral Solution
- Audience: Infectious disease specialists, pediatricians, pharmacists, other healthcare professionals
[Posted 08/14/2007] Abbott Laboratories disseminated a Dear Healthcare Provider Letter throughout the world to physicians and pharmacists that prescribe/distribute Kaletra Oral Solution. The letter informed healthcare professionals of an accidental overdose that occurred with a pediatric patient taking Kaletra Oral Solution. The infant received a significantly large dose of Kaletra and subsequently died. Healthcare professionals should pay special attention to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors.
[August 13, 2007 - Dear Healthcare Professional Letter - Abbott]
[March 2007 - Prescribing Information - Abbott]
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- Red Yeast Rice
Red Yeast Rice/Policosonal Complex
Cholestrix
- Audience: Consumers and healthcare professionals
[Posted August 09, 2007] FDA warns consumers and healthcare professionals to avoid using Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics because the products may contain an unauthorized drug that could be harmful to their health. The products, promoted and sold over the internet as treatments for high cholesterol, contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for high cholesterol.
Lovastatin can cause severe muscle problems leading to kidney impairment. The risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions such as nefazodone (an antidepressant), certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol lowering agents. Consumers who use any red yeast rice products should consult their healthcare provider if they experience any problems that may be due to these products.
[August 09, 2007 - News Release - FDA]
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- Omeprazole (marketed as Prilosec and generic products)
Omeprazole + Sodium Bicarbonate (marketed as Zegerid)
Nexium (esomeprazole)
- Audience: Gastroenterologists, other healthcare professionals, consumers
[UPDATE 12/11/2007] FDA informed healthcare professionals of the issuance of the Agency's follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the "Update of Safety Review" for information regarding the two studies that were reviewed.
[Posted August 09, 2007] FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec and Nexium. The new safety data was from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD). In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD.
The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.
Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec is also sold over the counter for frequent heartburn.
[December 10, 2007 - Update of Safety Review - Omeprazole and Esomeprazole - FDA]
[August 09, 2007 - Early Communication About an Ongoing Safety Review - Omeprazole and Esomeprazole - FDA]
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- Baxter Healthcare Corporation COLLEAGUE And FLO-GARD Volumetric Infusion Pumps
- Audience: Hospital administrators, hospital risk managers, healthcare professionals, and consumers
[UPDATE 09/25/2007] Recall classified as Class I because there is a reasonable probability that use of the product will cause serious injury or death.
[UPDATE 08/14/2007] Baxter Healthcare and FDA notified healthcare professionals that certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps sent to Baxter Healthcare Corporation for service, repair, or for correction may have been returned to users without service being performed on them. The company discovered falsified repair, test and inspection data sheets, including electrical safety data, for some of the referenced pumps serviced at its Phoenix, Arizona facility.
[UPDATE 08/08/2007] Baxter Healthcare and FDA notified healthcare providers and consumers that the July 25, 2007, Class I Recall of COLLEAGUE Infusion Pumps was expanded to include an additional 986 COLLEAGUE infusion pumps. The pumps should be returned to the company for repeat inspection because of falsified electrical safety data. See the Recall notice for the list of pumps affected by this recall.
[Posted 07/27/2007]
Baxter Healthcare and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter COLLEAGUE and FLO-GARD Volumetric Infusion Pumps, Model numbers 2M8151 and 2M8153, COLLEAGUE CX Volumetric Infusion Pumps, Model numbers 2M8161 and 2M8163, and FLO-GARD Volumetric Infusion Pumps Model numbers 2M8063 and 2M8064.
The products were recalled because the firm identified repair, inspection, test data sheets, which included electrical safety data for the pumps, that were falsified. As a result it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. This may result in over/under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can lead to death. Return the affected pumps to Baxter Healthcare for repeat inspections and servicing. COLLEAGUE and FLO-GARD customers with questions should contact Baxter Healthcare Corp. at 1-800-422-9837.
[September 25, 2007 - Updated Recall Notice - FDA]
[August 14, 2007 - Preliminary Public Health Notification - FDA]
[August 07, 2007 - Updated Recall Notice - FDA]
[July 27, 2007 - Recall Notice - FDA]
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- Thoratec Paracorporeal Ventricular Assist System (PVAD)
- Audience: Cardiologists, hospital administrators, healthcare professionals, and patients
[Posted July 27, 2007] Thoratec Corporation and FDA notified healthcare professionals and patients of a Class I Recall of Thoratec Paracorporeal Ventricular Assist System (PVAD), Model TLC-II, Catalog No. 14086-2550-000. A ventricular assist device is a mechanical pump that helps a person's heart that is too weak to pump blood through the body. The VAD is designed to provide sufficient blood flow to the damaged or diseased heart.
The product was recalled because the PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use. Dispose of any expired original design cannula. Do not use the black collet and nut with any design VAD. Make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula. Patients may call Thoratec Corporation at 1-925-847-8600.
[July 26, 2007 - Recall Notice - FDA]
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- Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver
- Audience: Cardiologists, hospital administrators, healthcare professionals, and patients
[Posted July 27, 2007] Thoratec Corporation and FDA notified healthcare professionals and consumers of a Class I Recall of Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver, Catalog No. 20010-0000-032. A Ventricular assist device is a mechanical pump that helps a person's heart that is too weak to pump blood through the body. The VAD is designed to provide sufficient blood flow to the damaged or diseased heart.
The product was recalled because the VAD support for the patient's circulatory system may fail. The VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours). The compressor motor can stop without warning. When the motor fails, there is a loss of VAD support for the patient, which results in inadequate blood flow to and from the heart. Check the current number of service hours on all units. Do not use the TLC-II drivers exceeding 1500 hours until they are serviced by Thoratec. Ensure that all patients have a back-up driver and hand pumps at all times and have been trained in backup procedures. When the 1500 hour limit has been reached, patients must stop using the device and send it to the manufacturer for servicing. Patients should replace all drivers at 1500 hours and go back to the hospital for a new backup replacement. Patients may call the company at 1-925-847-8600.
[July 26, 2007 - Recall Notice - FDA]
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- Baxter Healthcare Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps
- Audience: Hospital administrators, hospital risk managers, healthcare professionals, and consumers
[Posted July 20, 2007] Baxter Healthcare Corp. and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. These electronic infusion pumps are used to deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct line into the bloodstream.
The product was recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels infusing fluids at the same time. There are reports of serious injuries that are associated with this issue. In reported cases, the pump stopped infusing which caused it to activate an audible and a visual alarm. Interruption of life-sustaining therapy could lead to serious injury or death. Remove all the affected triple channel pumps from service immediately. COLLEAGUE customers with questions should contact Baxter Medical Delivery Services at 1-800-843-7867.
[July 20, 2007 - Recall Notice - FDA]
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Bayer Ascensia Contour Blood Glucose Monitoring System
- Audience: Endocrinologists, healthcare professionals, diabetic patients, and pharmacies
[Posted 07/13/2007] Bayer Healthcare and FDA notified healthcare professionals and consumers of a Class 1 Recall of Bayer Ascensia Contour Blood Glucose Monitoring System, Product 7152A. This system is used by diabetic patients to measure the amount of glucose in their blood, and as an aid in monitoring the effectiveness of diabetes management.
The product was recalled because the meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Consumers may misinterpret the blood glucose results displayed, overestimate the blood glucose levels, and may have a reaction of hypoglycemia. Patients with questions should call Bayer Healthcare at 1-574-256-3441.
[July 13, 2007 - Recall Notice - FDA]
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Rocephin (ceftriaxone sodium) for Injection
- Audience: Neonatologists, pediatricians, infectious disease specialists, hospital administrators, other healthcare professionals
[UPDATED 09/11/2007] Roche informed healthcare professionals about revisions made to the prescribing information for Rocephin to clarify the potential risk associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products.
Healthcare professionals are advised that Rocephin and calcium-containing solutions including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. Rocephin and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient. No data are available on the potential interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).
[Posted 07/05/2007] Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of the prescribing information for Rocephin for Injection. The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin. The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone.
[August 2007 - Dear Healthcare Professional Letter - Roche]
[August 2007 - Prescribing Information - Roche]
[September 11, 2007 - Healthcare Professional Sheet - FDA]
Previous MedWatch alert links
[May 2007 - Prescribing Information - Roche]
[June 2007 - Dear Healthcare Professional Letter - Roche]
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Invanz (ertapenem sodium) Injection
- Audience: Infectious disease specialists, hospital administrators and pharmacists, other healthcare professionals
[Posted 07/05/2007] Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.
[July 02, 2007 - Dear Healthcare Professional Letter - Merck]
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Colistimethate (marketed as Coly-Mycin M and generic products)
- Audience: Pulmonologists, respiratory therapists, compounding pharmacists, other healthcare professionals, cystic fibrosis patients
[Posted 06/28/2007] FDA notified healthcare professionals and cystic fibrosis patients that the Agency is investigating the possible connection between the use of a liquid solution of Colistimethate that was premixed for inhalation with a nebulizer and the death of a patient with cystic fibrosis (CF). Colistimethate is FDA approved for intravenous or intramuscular injection for the treatment of acute or chronic infections due to sensitive strains of certain Gram-negative bacilli, particularly sensitive strains of Pseudomonas aeruginosa which are a significant problem for patients with CF and for patients with neutropenia, and/or immune system compromise. The product is not FDA approved for use as a liquid to be inhaled via nebulizer. In this case, the drug was prepared by a pharmacy and dispensed as prescribed in premixed unit dose ready-to-use vials. Once Colistimethate is mixed into a liquid form, the product breaks down into other chemicals that can damage lung tissue.
Healthcare professionals who choose to prescribe Colistimethate to treat patients with CF should be aware of the potential for serious and life threatening side effects from inhalation of pre-mixed, ready-to-use liquid forms of the product. Patients should discard any unused pre-mixed liquid forms of Colistimethate.
[June 28, 2007 - Healthcare Professional Information Sheet - FDA]
[June 28, 2007 - Public Health Advisory - FDA]
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Propofol (marketed as Diprivan and generic products)
- Audience: Surgeons, anesthesiologists, healthcare professionals
[Posted 06/15/2007] FDA informed healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. Multiple vials and several lots of propofol used in patients who experienced these symptoms were tested and there was no evidence that the propofol vials or prefilled syringes used were contaminated with bacteria or endotoxins. Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow the recommendations for handling and use in the product's full prescribing information.
[June 15, 2007 - Drug Information Page - FDA]
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RotaTeq (Rotavirus, Live, Oral, Pentavalent) Vaccine
- Audience: Pediatric healthcare professionals, consumers
[Posted 06/15/2007] FDA informed healthcare professionals of changes to the ADVERSE REACTIONS and POST-MARKETING sections of the product's prescribing information. The ADVERSE REACTIONS section was updated to include six cases of Kawasaki disease that were observed during the Phase 3 clinical trial. There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. The POST-MARKETING section of the prescribing information was revised to reflect three reports of Kawasaki disease to the Vaccine Adverse Event Reporting System (VAERS) since licensure on February 3, 2006. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease.
Kawasaki disease is a serious, but uncommon illness in children that is poorly understood and the cause has not been determined. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart. The cases reported to date are not more frequent than what could be expected to occur by coincidence. FDA and the Centers for Disease Control and Prevention will continue to monitor the safety of RotaTeq and all vaccines and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq, as well as other vaccines, be reported to VAERS.
[June 15, 2007 - Information Page - FDA]
[June 15, 2007 - Label - Merck]
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- Long Weekend Dietary Supplement
- Audience: Consumers, healthcare professionals
[Posted 06/15/2007] Confidence, Inc. informed consumers and healthcare professionals of a nationwide recall of Long Weekend, a product sold as a dietary supplement through mail orders and retailers located nationwide, and in Puerto Rico, Canada, the United Kingdom, Russia, and China. The product was recalled because it contained undeclared tadalafil, an FDA approved drug used to treat male Erectile Dysfunction (ED). This poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Long Weekend is not approved by FDA; therefore, the safety and effectiveness of this product is unknown. Consumers should discontinue use of Long Weekend and consult their healthcare professional about approved treatments for ED.
[June 14, 2007 - News Release - Confidence, Inc.]
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- Abbott Laboratories Architect Stat Troponin-1 Immunoassay
- Audience: Hospital Risk Managers, hospital administrators, clinical laboratories, healthcare professionals
[Posted 06/08/2007] Abbott Laboratories and FDA notified healthcare professionals of a Class I Recall of the Architect Stat Troponin-1 Immunoassay. Doctors use this test in diagnosing damage to the heart and/or a heart attack in people who have had chest pain. The product was recalled after a small number of clinical laboratories reported inconsistent or invalid test results at very low levels of troponin-1 (i.e., less than 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may impact patient treatment. Laboratories are advised to be cautious when reporting results at or near the lower limit of detection and to advise physicians ordering the tests about the possibility of inaccurate results at those levels.
[June 08, 2007 - Recall Notice - FDA]
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- Alcon Refractive Horizons LADAR6000 Excimer Laser System
- Audience: Ophthalmologists, patients
[Posted 06/05/2007] Alcon Refractive Horizons and FDA notified healthcare professionals and patients of a Class I Recall of the LADAR6000 Excimer Laser System for CustomCornea algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7). This system is used for LASIK and wave-front guided LASIK treatment for the reduction or elimination of mild to moderate nearsightedness (myopia) and farsightedness (hyperopia) with or without astigmatism or for mixed astigmatism in patients who are 21 years of age or older with documented stability of refraction for the prior 12 months.
The product was recalled because use of the Alcon Refractive Horizons CustomCornea algorithm for myopia with and without astigmatism with the LADAR6000 Excimer Laser caused corneal abnormalities ("central islands") and decreased visual sharpness (visual acuity) in patients. These "central islands" may not be correctable with lasers and the decrease in visual acuity may not be correctable with glasses or contact lenses. Patients with questions should call the company at 1-877-523-2784.
[June 05, 2007 - Recall Notice - FDA]
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- Toothpaste Imported From China May Contain Diethylene Glycol
- Audience: Consumers, healthcare professionals
[UPDATE 08/13/2007] Gilchrist & Soames, an Indianapolis- based provider of toiletry products for the hotel industry, initiated a worldwide voluntary recall of its Gilchrist & Soames 0.65oz/18ml toothpaste manufactured in China. Independent tests showed some samples of the toothpaste contained diethylene glycol.
[UPDATE 08/08/2007] Donnamax Inc. initiated a nationwide recall of DentaPro brand CAVITY FIGHTING FLUORIDE TOOTHPASTE, FRESH SPEARMINT FLAVOR, NET WT. 6.4 oz. - Item No. 9112, UPC 8 71290 – 00062 5, and Bright Max Toothpaste, NET WT. 6.4 oz. - Item No. 9111, made in China. The recall was initiated because the products may contain the poisonous chemical, diethylene glycol (DEG), an ingredient used in antifreeze. Consumers should stop using the products and either throw them away or return them to the place of purchase.
[UPDATE 07/16/ 2007] DentFresh USA initiated a nationwide recall of DentFresh Fluoride Mint Toothpaste 9 Oz (255g) made in China. The recall was initiated because the product may contain the poisonous chemical, diethylene glycol (DEG), an ingredient used in antifreeze. Consumers should stop using the product and either throw it away or return it to the place of purchase. Consumers with questions may contact DentFresh at denfresh@hotmail.com or at 305-677-9938.
[UPDATE 06/15/2007] MainStar America initiated a nationwide recall of toothpaste made in China. The recall was initiated because the products may contain the poisonous chemical diethylene glycol. Consumers who have one of the recalled products should stop using the product, return the product to the store where it was purchased, or throw the product away. See the Firm's press release for a list of product lot numbers associated with this recall.
[UPDATE 06/14/2007] The Colgate-Palmolive Company warned that counterfeit toothpaste falsely packaged as "Colgate" has been found in several dollar-type discount stores in New York, New Jersey, Pennsylvania, and Maryland. There are indications that the product does not contain fluoride and may contain diethylene glycol. Consumers who suspect they may have purchased a counterfeit product can call Colgate's toll-free number 1-800-468-6502.
[UPDATE 06/13/2007] Gold City Enterprise LLC of Hallandale, Florida initiated a nationwide recall of toothpaste made in China because the products may contain the poisonous chemical diethylene glycol (DEG), a substance used in antifreeze and as a solvent. The substance is a central nervous system depressant and potent kidney and liver toxin. See the company's news release for a listing of the lot numbers for the recalled products. Additionally, Pitusa, National Lumber, Everything to Weight, Supermarkets and Supermarkets Pitusa of Carolina, Puerto Rico recalled all dental toothpaste with the origin "Made in China" due to possible contamination with DEG. The recall includes the following product sizes with dental brushes, 6.4 oz, 1.76 oz, and 50 grams for children. See the Pitusa, National Lumber's news release for the various names under which the recalled products are sold.
[Posted 06/01/2007] FDA warned consumers to avoid using tubes of toothpaste labeled as "Made in China". The warning and an import alert were issued to prevent toothpaste containing a poisonous chemical, diethylene glycol (DEG) from entering the United States from China. The substance is used in antifreeze and as a solvent. Although FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG, FDA is concerned about chronic exposure to DEG and exposure to the product in certain populations, such as children and individuals with kidney or liver disease. Toothpaste containing DEG has a low but meaningful risk of toxicity and injury to these populations. Consumers should examine their toothpaste and dispose of any products listing the ingredient "diethylene glycol" also known as "diglycol". See the News Release for the brands of toothpaste from China that contain DEG that are included in the import alert.
[August 13, 2007 - Press Release - Gilchrist & Soames]
[August 08, 2007 - News Release - Donnamax, Inc.]
[July 13, 2007 - News Release - DentFresh]
[June 13, 2007 - News Release - MainStar America]
[June 14, 2007 - News Release - Colgate–Palmolive]
[June 13, 2007 - DEG in Toothpaste from China - FDA]
[June 08, 2007 - News Release - Gold City Enterprise LLC]
[June 08, 2007 - News Release - Pitusa, National Lumber, Everything To Weight, Supermarkets Pitusa]
[June 01, 2007 - News Release - FDA]
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- Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron
- Audience: Consumers, healthcare professionals
[Posted 05/29/2007] Abbott informed consumers and healthcare professionals of a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital. The three lots of formula were recalled because they do not contain as much iron as indicated on the label. The formula was distributed in the United States between November 2006 and May 2007. Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake. If parents have concerns about their baby's health, they should contact their baby's doctor or healthcare professional. No other liquid or powdered Similac Infant formulas were affected. See the attached manufacturer's press release for a list of stock code and lot numbers for formula affected by this recall.
[May 25, 2007 - News Release - Abbott]
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- Advanced Medical Optics Complete MoisturePLUS Multipurpose Contact Lens Solution
- Audience: Consumers, ophthalmologists, opticians, other healthcare professionals
[UPDATE 08/01/07] Recall of COMPLETE MoisturePLUS Multi-purpose Contact Lens Solution manufactured by Advanced Medical Optics, Inc. classified by FDA as Class I. See the Recall notice for the list of affected products.
[UPDATE 08/01/07] FDA announced that many consumers may not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involve the use of AMO Complete MoisturePLUS after the recall was announced. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePLUS product immediately, discard all remaining solution including partially used or unopened bottles. See the FDA Preliminary Public Health Notification dated May 31, 2007, for recommendations for contact lens wearers.
[UPDATE 05/31/07] FDA issued a Preliminary Public Health Notification to inform healthcare professionals of a recent increase in reported cases of Acanthamoeba keratitis in soft contact lens wearers. The infections are potentially related to the use of Complete MoisturePLUS Multipurpose Contact Lens Solution.
[Posted 05/29/2007] Advanced Medical Optics and FDA informed healthcare professionals and consumers who wear soft contact lenses of a recall of Complete MoisturePLUS Multi-Purpose Solution. The recall was based on reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention. Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses. Symptoms of the infection can be very similar to those of other more common eye infections include eye pain or redness, blurred vision, light sensitivity, the sensation of something in the eye or excessive tearing, but Acanthamoeba is more difficult to treat. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePLUS product immediately, discard all remaining solution including partially used or unopened bottles, and ask their healthcare professional about choosing an appropriate alternative cleaning/disinfecting product. Individuals should seek immediate treatment if they have symptoms of an eye infection as early diagnosis is important for effective treatment.
[August 01, 2007 - Recall Notice - FDA]
[May 31, 2007 - Preliminary Public Health Notification - FDA]
[May 26, 2007 - News Release - FDA]
[May 25, 2007 - News Release - Advanced Medical Optics]
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- Unapproved Guaifenesin Timed-Release Drug Products
- Audience: Consumers, healthcare professionals
[Posted 05/25/2007] FDA informed consumers and healthcare professionals of its intent to take action against companies that market unapproved timed-release dosage form of guaifenesin products, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from the lungs. These dosage forms are often described as extended-release, long-acting or sustained-release products that release their active ingredients over an extended period of time, reducing the number of doses needed per day. Approximately 20 firms make unapproved timed-release products containing guaifenesin that have not undergone FDA review for safety and efficacy. Mucinex, Mucinex-D, Mucinex-DM, and Humibid are the only FDA approved timed-release guaifenesin (single ingredient or combination) products. Companies marketing unapproved products containing guaifenesin in timed-release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. This action does not affect products containing guaifenesin in immediate release form.
[May 25, 2007 - News Release - FDA]
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-
- Integra LifeSciences EnDura No-React Dural Substitute
- Audience: Hospital Administrators, hospital risk managers, healthcare professionals, patients
[UPDATE 05/31/2007] Recall classified by FDA as Class I.
[Posted 05/25/2007] Integra LifeSciences (Integra) informed healthcare professionals and patients of a recall of all EnDura No-React Dural Substitute (EnDura) products. The products are manufactured by Shelhigh, Inc. and distributed by Integra. The recall is pursuant to an April 18, 2007, FDA Public Health Notification regarding products manufactured by Shelhigh, citing sterility and other manufacturing concerns and FDA's request that Shelhigh recall all of its medical devices remaining in the marketplace. Integra is recalling all Endura products that may be in the field from the date of the first shipment by Integra in 2003 to present. On May 18, 2007, FDA classified the recall as Class I.
A Class I recall is assigned when there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death. See the attached manufacturer's press release for a list of products affected by this recall.
[May 31, 2007 - Recall Notice - FDA]
[May 25, 2007 - News Release (PDF) - Integra LifeSciences]
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- Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (MRI): marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance
- Audience: Radiologists, Nephrologists, Dermatologists, other healthcare professionals
[UPDATED 09/28/2007] Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents as listed above used in Magnetic Resonance Imaging (MRI).
[Posted 05/23/2007] FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of nephrogenic systemic fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging.
[September 2007 - Letter - Bayer, GE-Healthcare, BRACCO, and MALLINCKRODT]
[May 2007 - Magnevist label - Bayer Healthcare Pharmaceuticals]
[May 2007 - MultiHance label - Bracco Diagnostics Inc.]
[September 2007 - Omniscan label - GE Healthcare]
[May 2007 - OptiMARK label - Mallinckrodt Inc.]
[May 2007 - ProHance label - Bracco Diagnostics, Inc.]
[May 23, 2007 - News Release - FDA]
[May 23, 2007 - Information for Healthcare Professionals - FDA]
[May 23, 2007 - Q&A - FDA]
Previous MedWatch Alerts:
[June 08, 2006]
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-
- Exjade (deferasirox) Tablets For Oral Suspension
- Audience: Oncologists, Hematology-Oncologists, Pediatric Hematologists, Specialty Pharmacists
[UPDATE 12/13/2007] Novartis informed healthcare professionals of changes made to the WARNINGS, ADVERSE REACTIONS, and DOSAGE and ADMINISTRATION sections of prescribing information for Exjade Tablets for Oral Suspension. The WARNINGS and ADVERSE REACTIONS sections of the labeling were revised to include information about postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure.
[Posted 05/22/2007] Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Cases of acute renal failure, some with a fatal outcome, have been reported following the post marketing use of Exjade. Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders. Additionally, there were post marketing reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in patients treated with Exjade where some of the patients died. The relationship of these episodes to treatment with Exjade is uncertain. Most of these patients had preexisting hematologic disorders that are frequently associated with bone marrow failure. Further, cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions (including anaphylaxis and angioedema) were reported.
Healthcare professionals should monitor serum creatinine in patients who are at increased risk of complications, having preexisting renal conditions, are elderly, have co-morbid conditions, or are receiving medicinal products that depress renal function. Blood counts should also be monitored regularly and treatment should be interrupted in patients who develop unexplained cytopenia.
[December 12, 2007 - Dear Healthcare Professional Letter - Novartis]
[May 14, 2007 - Dear Healthcare Professional Letter - Novartis]
[April 2007 - Label - Novartis]
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-
- Avandia (rosiglitazone)
- Audience: Endocrinologists, other healthcare professionals, consumers
[Posted 05/21/2007] FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.
[May 21, 2007 - Healthcare Professional Information Sheet - FDA]
[May 21, 2007 - News Release - FDA]
[April 2007 - Prescribing Information - GlaxoSmithKline]
Previous MedWatch Alerts:
[February 20, 2007]
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-
- Caffeine Citrated, Powder, Purified
- Audience: Hospital risk managers, pediatricians, pharmacists, other healthcare professionals
[Posted 05/21/2007] Spectrum and FDA informed healthcare professionals of a nationwide recall of 3 lots (TS0225, UK0821, and V11203) of Caffeine Citrated, Powder, Purified. The product was recalled because of complaints about potential sub potency. Caffeine Citrated is a cerebral and respiratory stimulant used primarily to treat idiopathic apnea of premature infants. Blood levels of caffeine in patients were determined to be significantly lower than would be expected. The use of sub-potent compounded preparations may lead to sub-therapeutic caffeine blood levels and an unacceptable risk of respiratory depression. Customers should examine their inventory, discontinue dispensing and using the product, quarantine the referenced lots of the product. and call the manufacturer to arrange to return the product for credit or replacement.
[May 17, 2007 - Recall Quick Facts - Spectrum]
[May 17, 2007 - Customer Survey - Spectrum]
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-
- NBTY Shark Cartilage Capsules
- Audience: Consumers, healthcare professionals
[UPDATE 06/06/07] Action Labs recalled its Sentinel brand of Shark Cartilage capsules manufactured by NBTY in 2005 because the product may be contaminated with Salmonella.
[Posted 05/17/2007] NBTY and FDA informed consumers and healthcare professionals of a nationwide recall of 3 lots of Shark Cartilage Capsules the company manufactured in 2004 and distributed to consumers through mail and internet orders, and retail stores throughout the United States. The product was recalled because of possible contamination with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis and arthritis. Customers can return the product back to the place of purchase for a full refund. Read the press release for specific names and lot numbers of the recalled product.
[June 06, 2007 - Press Release - NBTY]
[May 16, 2007 - Press Release - NBTY]
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- OxyContin, Illegal Promotion by Manufacturer May Cause Health Risks for Consumers
- Audience: Pain management specialists, healthcare professionals, consumers
[Posted 05/10/2007] FDA informed healthcare professionals of criminal charges and civil liabilities brought against Purdue Frederick in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces. The manufacturer's sales force was trained to make false claims about the product to healthcare professionals, thereby, misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications. These practices falsely promote the product and may cause health risks for consumers.
[May 10, 2007 - News Release - FDA]
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-
- True Man and Energy Max Products
- Audience: Consumers, healthcare professionals
[UPDATE 11/21/2007] American True Man Health Inc., expanded its recall of dietary supplement products to include Energy Max, Energy Supplement Men's Formula with the expiration date up to and including December 2010.
[UPDATE 11/05/2007] FDA has requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, both illegal drug products that contain potentially harmful, undeclared ingredients. This recall request comes as a result of the company previously failing to notify all of their consignees, and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules.
[Posted 05/10/2007] FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary supplements throughout the United States. Both products, promoted as sexual enhancement products and as treatment for erectile dysfunction (ED), are illegal drug products that contain potentially harmful, undeclared ingredients. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Both products contain either a thione analog of sildenafil, the active ingredient in Viagra, or a piperadino analog of vardenafil, the active ingredient in Levitra. Both Viagra and Levitra are FDA approved products for the treatment of ED. FDA has not approved True Man and Energy Max, therefore, the safety and effectiveness of these products are unknown. Consumers should discontinue use of these products and consult their healthcare professional about approved treatments for ED.
[November 16, 2007 - Firm Press Release - FDA]
[November 02, 2007 - News Release - FDA]
[May 10, 2007 - News Release - FDA]
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-
- Glycerin compounded products
- Audience: Pharmaceutical manufacturers, suppliers, drug repackers, compounding healthcare professionals
[Posted 05/07/2007] FDA warned pharmaceutical manufacturers, suppliers, drug repackers, and healthcare professionals who compound medications using glycerin of the importance of assuring that the glycerin used is not contaminated with diethylene glycol (DEG), a known poison used in antifreeze and as a solvent. Glycerin is a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products. Although FDA has no reason to believe that the U. S. supply of glycerin is contaminated with DEG, it is aware of reports from other countries over the past several years in which DEG contaminated glycerin has caused human deaths. FDA emphases the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem. FDA issued guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before using glycerin in the manufacture or preparation of pharmaceutical products.
[May 04, 2007 - News Release - FDA]
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-
- Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products Troponin I Reagent Pack
- Audience: Hospital Risk Managers, hospital administrators, clinical laboratories, healthcare professionals
[UPDATE 05/22/2007] Recall classified by FDA as Class I.
[Posted 05/07/2007] Ortho-Clinical Diagnostics and FDA notified healthcare professionals of a nationwide recall of the Vitros Immunodiagnostic Products Troponin I Reagent Pack, Lots 3151 and 3170. The product was recalled after a small number of clinical laboratories administering the test reported shifts in quality control results causing the potential for false negative troponin I results at very low levels. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when it fact they had.
A troponin I test is usually ordered with other cardiac tests in the hospital to determine if a patient has had a heart attack or injury to the heart muscle. The identified product lots were distributed to clinical laboratories within and outside the United States between January and March of 2007. Clinical laboratories in possession of the identified lots are instructed to discontinue use of the product and notify healthcare professionals who ordered the test in recent weeks.
[May 22, 2007 - Recall Notice - FDA]
[May 04, 2007 - Press Release - Ortho-Clinical Diagnostics]
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- Antidepressant Medication Products
- Audience: Healthcare professionals, consumers
[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes.
[May 02, 2007 - Press Release - FDA]
[May 02, 2007 - Antidepressant Information Page - FDA]
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- Colchicine Compounded Injectable Products
- Audience: Healthcare professionals
[Posted 05/02/2007] ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine 0.5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product for return to the company.
[April 30, 2007 - Recall Notice - ApothéCure]
[April 30, 2007 - Return Fax Cover - ApothéCure]
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- Warning About Counterfeit Drugs From Multiple Internet Sellers
- Audience: Consumers, healthcare professionals
[UPDATE 11/02/2007] A year-long investigation by FDA suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the internet. FDA urges consumers to beware of unregulated internet drug sellers, because many of their products might not contain the correct ingredients and could contain toxic substances.
[Posted 05/01/2007] FDA informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over the internet. FDA received information showing that 24 apparently related websites may be involved in the distribution of counterfeit prescription drugs. The websites appear to be operated from outside the United States.
On three occasions during recent months, consumers obtained counterfeit versions of Xenical 120mg Capsules, a drug used to help obese individuals who meet certain weight and height requirements to lose weight and maintain weight loss, from two different websites. Instead of receiving Xenical, a product manufactured by Hoffmann-LaRoche, consumers received sibutramine, the active ingredient in Meridia. Although Meridia is also used to help individuals lose weight and maintain weight loss, the drug should not be used in certain patient populations and is not a substitute for other weight loss products. Consumers should be wary if there is no way to contact the website pharmacy by phone, if prices are dramatically lower than the competition, or if a prescription from their doctor is not required. Additionally, consumers are urged to review the FDA web page at www.fda.gov/buyonline for additional information prior to making purchases of prescription drugs over the internet. See the FDA press release for the list of the 24 web sites that may be involved in the distribution of counterfeit prescription drugs.
[November 01, 2007 - Press Release - FDA]
[May 01, 2007 - Press Release - FDA]
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- PharmaFab Inc., manufacturer and distributor of prescription and over-the-counter drug products
- Audience: Consumers, healthcare providers
[Posted 04/25/2007] FDA announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. Compliance with CGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity.
PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician.
[April 25, 2007 - Press Release - FDA]
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- ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP): S8 Compact, S8 Escape, S8 Elite, and S8 AutoSet Vantage
- Audience: Consumers, respiratory healthcare providers, and risk managers
[Posted 04/24/2007] ResMed and FDA notified consumers and healthcare professionals of a worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure or CPAP) used for the treatment of obstructive sleep apnea. In Model S8 devices manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator. See recall notice for serial numbers for affected S8 models.
Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement.
[April 23, 2007 - Press Release - ResMed]
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- Avastin (bevacizumab)
- Audience: Oncological and other healthcare professionals
[Posted 04/21/2007] Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin. There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment.
Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin.
[April, 2007 - Dear Healthcare Professional Letter - Genentech]
[October, 2006 - Avastin Label - Genentech]
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- Shelhigh, Inc. Implantable Medical Devices
- Audience: Cardiovascular, neurosurgical and other surgical healthcare professionals, hospital risk managers, consumers
[UPDATE 06/25/2007] FDA informed healthcare professionals of the United States District Court for the District of New Jersey's consent order of injunction, agreed to by Shelhigh, that forbids Shelhigh from distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with FDA standards.
[UPDATE 05/18/2007] FDA informed healthcare professionals that all medical devices manufactured by the company were manufactured under conditions that may have contaminated the devices and may result in devices that fail to function for the expected life of the products.
[UPDATE 05/02/2007] Recall expanded to include all Shelhigh medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.
[UPDATE 04/21/2007] Preliminary Public Health Notification and Preliminary Advice for Patients updated, based on information obtained during seizure.
[Posted 04/18/2007] FDA seized all implantable medical devices from Shelhigh, Inc., after finding significant deficiencies in the company’s manufacturing processes. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.
Physicians should use alternative devices. Physicians should also monitor patients with any Shelhigh implants for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information.
[June 25, 2007 - News Release - FDA]
[May 18, 2007 - Updated Preliminary Public Health Notification - FDA]
[May 02, 2007 - News Release - FDA]
[April 19, 2007 - Updated Preliminary Public Health Notification - FDA]
[April 19, 2007 - Updated Preliminary Advice for Patients - FDA]
[April 18, 2007 - Preliminary Public Health Notification - FDA]
[April 18, 2007 - Preliminary Advice for Patients - FDA]
[April 17, 2007 - Press Release - FDA]
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- Boston Scientific/Guidant CONTAK RENEWAL 3 and 4,
VITALITY, and
VITALITY 2 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators
- Audience: Cardiac healthcare professionals, risk managers, patients
[Posted 04/12/2007] Boston Scientific/Guidant and FDA informed healthcare professionals and patients that a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families were recalled. The recall included approximately 73,000 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because of faulty capacitors. The capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator and end of life to less than three months. Although the current recall is similar to the recall of May 2006, the failure modes and patient outcomes differ from those described in the May 2006 recall. Patients with one of the recalled devices should contact their healthcare provider regarding the next steps to take.
[April 5, 2007 - Dear Doctor Letter - Boston Scientific]
[April 10, 2007 - Q&A - FDA]
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- Zanaflex (tizanidine hydrochloride) Tablets and Capsules
- Audience: Healthcare professionals
[Posted 04/11/2007] Acorda Therapeutics and FDA informed healthcare professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the product labeling for Zanaflex, a drug used to treat spasticity. In pharmacokinetic studies where tizanidine was coadministered with either fluvoxamine or ciprofloxacin (CYP1A2 inhibitors), the serum concentration of tizanidine was significantly increased and potentiated its hypotensive and sedative effects. Although there are no clinical studies evaluating the effects of other CYP1A2 inhibitors on tizanidine, coadministration of tizanidine with other CYP1A2 inhibitors (zileuton, other fluroquinolones, antiarrythmics, cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine) should be avoided.
[March 27, 2007 - Letter - Acorda Therapeutics]
[July 2006 - Label - Acorda Therapeutics]
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- Ziagen (abacavir sulfate) Tablets
Combivir (lamivudine and zidovudine) Tablets
- Audience: Pharmacists, other healthcare professionals
[Posted 04/10/2007] GlaxoSmithKline and FDA informed healthcare professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit labels for Combivir Tablets. Both medications are used as part of combination regimens to treat HIV+ infection. Two 60-count misbranded bottles of Combivir Tablets contained 300 mg tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009. The incident appears to be isolated and limited in scope to one pharmacy in California. Pharmacists should immediately examine the contents of each bottle of Combivir in their pharmacy to confirm that the bottles contain the correct medication. The Dear Pharmacy Professional Letter contains photos of actual Combivir and Ziagen Tablets. If a bottle contains anything other than Combivir Tablets, pharmacists should notify the manufacturer.
[March 29, 2007 - Letter - GlaxoSmithKline]
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- Grifulvin V (griseofulvin) Oral Suspension
Griseofulvin Oral Suspension
- Audience: Pediatricians, other healthcare professionals, consumers
[Posted 04/10/2007] Ortho-McNeil and FDA informed healthcare professionals and consumers of a nationwide recall of griseofulvin oral suspension, a prescription medication used to treat ringworm and other fungal infections. The recall was issued based on two reports of glass fragments found in bottles of the liquid formulation. The recall is limited to the liquid formulation of the medication and does not include any other dosage form. Consumers in possession of the medication should contact the pharmacy where they purchased the drug to determine if they have the product that has been recalled and direct medical questions to their healthcare professional.
[April 10, 2007 - News Release - Ortho-McNeil]
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- Trimethobenzamide hydrochloride Suppositories
- Audience: Healthcare professionals, consumers
[Posted 04/06/2007]
FDA notified healthcare professionals and consumers that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting in adults and children. The products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. This action does not affect oral capsules and injectable products containing trimethobenzamide that have been approved by FDA. FDA urges consumers currently using trimethobenzamide suppositories or who have questions or concerns to contact their healthcare professional. Alternative products approved to effectively treat nausea and vomiting are available in a variety of forms.
[April 6, 2007 - News Release - FDA]
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- Zelnorm (tegaserod maleate)
- Audience: Gastroenterologists, other healthcare professionals, consumers
[UPDATE 07/27/2007] FDA announced that it is permitting the restricted use of Zelnorm under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug. Zelnorm will remain off the market for general use. Physicians with IBS-C or CIC patients, who meet the IND criteria should contact Novartis at 888-669-6682 or 800-QUI-NTILE. Those who do not qualify for the Zelnorm treatment protocol may contact FDA's Division for Drug Information about other options at 888-463-6332.
[Posted 03/30/2007]
FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.
[July 27, 2007 - News Release - FDA]
[March 30, 2007 - Public Health Advisory - FDA]
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-
- Permax (pergolide) and generic equivalents
- Audience: Neurologists, other healthcare professionals, consumers
[Posted 03/29/2007]
FDA notified healthcare professionals and patients that companies that manufacture and distribute pergolide have agreed to withdraw the drug from the market. Pergolide is a dopamine agonist (DA) used with levodopa and carbidopa to manage the signs and symptoms of Parkinson's disease. Results of two new studies showed that some patients with Parkinson's disease treated with pergolide had serious damage to their heart valves when compared to patients who did not receive the drug. These two studies confirm earlier studies that also describe this problem. Patients currently taking pergolide should contact their healthcare professional about alternate treatments and not abruptly stop taking their medication. Healthcare professionals should assess their patient's need for DA therapy. If continued treatment with a DA is needed, another DA should be substituted for pergolide.
[March 29, 2007 - Public Health Advisory - FDA]
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-
- Accutane (isotretinoin)
- Audience: Consumers, healthcare professionals
[Posted 03/28/2007]
FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online. Isotretinoin is a drug approved for the treatment of severe acne that does not respond to other forms of treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.
The new webpage, http://www.fda.gov/buyonline/accutane, will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin.
[March 28, 2007 - Accutane Warning Page - FDA]
[October 06, 2006 - Accutane Information Page - FDA]
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-
- DermaFreeze365 Products
- Audience: Consumers, healthcare professionals
[Posted 03/28/2007] Woodridge Labs and FDA informed consumers and healthcare professionals of a recall of all lots of its DermaFreeze365 Instant Line Relaxing Formula and DermaFreeze365 Neck and Chest products. The products were recalled because certain lots tested positive for Pseudomonas aeruginosa bacteria. The bacteria may cause serious eye infections, urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Because DermaFreeze365 Instant Line Relaxing Formula may be applied in the area of the eye, there is a possibility that if the recalled product is inadvertently introduced in the eye, it could result in serious eye infections and, in rare circumstances, possible blindness.
[March 23, 2007 - Press Release - Woodridge Labs]
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-
- Smith & Nephew Radio Frequency (RF) Denervation Probes
- Audience: Hospital risk managers, surgical service personnel
[Posted 03/27/2007] FDA notified healthcare professionals of a nationwide Class I recall of RF Denervation probes used with the Smith & Nephew Electrothermal 20S Spine System in RF heat lesion procedures for the relief of pain. The product was mislabeled. The device is a non-sterile (not germ free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility prior to each use, including initial use. This error may result in infections with associated risks including, organ failure and/or death.
[March 27, 2007 - Recall Notice - FDA]
[March 26, 2007 - Press Release - Smith & Nephew]
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-
- V.MAX supplement product
- Audience: Consumers and healthcare professionals
[Posted 03/19/2007] Barodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have V.MAX in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
[March 15, 2007 - Press Release - Barodon SF]
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-
- Rhino Max (Rhino V Max) supplement product
- Audience: Consumers and healthcare professionals
[Posted 03/16/2007] Cosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max (Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
[March 16, 2007 - Press Release - Cosmos Trading, Inc.]
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-
- Zyvox (linezolid)
- Audience: Infectious disease specialists, other healthcare professionals
[Posted 03/16/2007] FDA notified healthcare professionals of new emerging safety concerns about Zyvox (linezolid) from a recent clinical study. This open-label, randomized trial compared linezolid to vancomycin, oxacillin, or dicloxacillin in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. Patients treated with linezolid had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection. Patients with Gram positive infections had no difference in mortality according to their antibiotic treatment. In contrast, mortality was higher in patients treated with linezolid who were infected with Gram negative organisms alone, with both Gram positive and Gram negative organisms, or who had no infection when they entered the study.
Linezolid is not approved for the treatment of catheter-related bloodstream infections, catheter-site infections, or for the treatment of infections caused by Gram negative bacteria. If infection with Gram negative bacteria is known or suspected, appropriate therapy should be started immediately.
[March 16, 2007 - Drug Information Page - FDA]
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-
- Sedative-hypnotic drug products
- Audience: Healthcare professionals, consumers
[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.
[March 14, 2007 - News Release - FDA]
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-
- Actimmune (Interferon Gamma 1-b)
- Audience: Pulmonologists, other healthcare professionals, consumers
[Posted 03/09/2007] FDA notified healthcare professionals of the early termination of the INSPIRE clinical study of Actimmune for idiopathic pulmonary fibrosis (IPF). The study was stopped because an interim analysis showed that patients with IPF who received Actimmune did not benefit. The trial compared survival in patients getting Actimmune or an inactive injection (placebo). An analysis showed that 14.5% of patients treated with Actimmune died as compared to 12.7% of patients treated with placebo. Actimmune is not approved by the FDA to treat IPF.
[March 09, 2007 - Public Health Advisory - FDA]
[March 09, 2007 - Drug Information Page - FDA]
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-
- Actos (pioglitazone) Tablets
ACTOplus met (pioglitazone and metformin hydrochloride) Tablets
Duetact (pioglitazone and glimepiride) Tablets
- Audience: Endocrinologists, other healthcare professionals, consumers
[Posted 03/09/2007]
Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.
[March 2007 - Letter - Takeda Pharmaceuticals North America, Inc.]
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-
- Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)
- Audience: Emergency services personnel, risk managers, consumers
[Posted 03/07/2007]
Defibtech and FDA notified healthcare professionals of a worldwide recall of 42,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software may allow a self-test to clear a detected low battery condition. The operator may be unaware of the low battery and the device may not deliver a defibrillation shock, resulting in failure to resuscitate a patient.
The company provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. The devices were distributed to schools, fire & EMS, businesses, health clubs and hospitality companies.
[March 07, 2007 - Recall Notice - FDA]
[March 06, 2007 - Firm Press Release - Defibtech]
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-
- Gebauer Salivart Oral Moisturizer
- Audience: Dentists, pharmacists, other healthcare professionals, patients
[Posted 03/05/2007] The Gebauer Company notified healthcare professionals and consumers of a nationwide recall of certain lots of Salivart Oral Moisturizer. The recall was initiated because some lots do not meet the Company's internal specification for aerobic microorganisms and mold. Use of the affected units may cause temporary and reversible health problems such as nausea, vomiting, and diarrhea. Customers who have the recalled product should stop using the product and dispose of it immediately. See the manufacturer's recall notice for specific lot numbers and expiration dates of the recalled product.
[ March 01, 2007 - Recall Notice - Gebauer]
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-
- Ergotamine tartrate
- Audience: Pharmacists, other healthcare professionals, consumers
[Posted 03/02/2007] FDA informed healthcare professionals and consumers that the Agency ordered twenty firms to stop marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. Unapproved drugs pose real risks to the American public because they have not been subject to FDA review, and the safety, effectiveness, and quality of such products are unknown. This action does not affect FDA-approved products containing ergotamine. Consumers who are using ergotamine products and have questions or concerns are urged to contact their health care provider.
[March 01, 2007 – News Release – FDA]
[March 01, 2007 – Warning Letters – FDA]
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- Medical Equipment That Uses or Displays Time
- Audience: Healthcare professionals, hospital directors and safety managers, consumers
[Posted 03/02/2007] FDA notified healthcare professionals and consumers of the possibility that some medical devices/equipment, hospital networks and associated information technology systems may generate adverse events because of the upcoming change in the start and end dates for Daylight Savings Time (DST), and suggested actions to prevent such occurrences. Medical equipment that uses, creates or records time information about a patient's diagnosis or treatment and has not been updated by the manufacturer, may not work properly when the new DST starts three weeks earlier and ends one week later this year. Medical equipment currently in use was likely made before the DST rules were changed and may cause patient's equipment to register the wrong dates for the start and end of daylight savings time this year.
Additionally, if a medical device or medical device network are adversely affected by the new DST date changes, a patient's treatment or diagnostic result could be:
- incorrectly prescribed
- provided at the wrong time
- missed
- given more than once
- given for longer or shorter durations than intended
- incorrectly recorded
Healthcare professionals and consumers are encouraged to see the attached Medical Device Safety Alert and Public Health Notification for recommendations on what to do if their medical equipment uses or displays time.
[March 01, 2007 – Preliminary Public Health Notification – FDA]
[March 01, 2007 – Advice for Patients – FDA]
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- Baraclude (entecavir) Tablets and Oral Solution
- Audience: Infectious disease specialists and other healthcare professionals
[UPDATE 08/16/2007] FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the following sections of the Baraclude prescribing information: BOXED WARNINGS, MICROBIOLOGY/Antiviral Activity against HIV (human immunodeficiency virus), WARNINGS/Co-infection with HIV, PRECAUTIONS/Information for Patients, and Patient Package Insert. Baraclude therapy is not recommended for HIV/hepatitis B virus (HBV) co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) due to the potential for the development of HIV resistance.
[Posted 02/24/2007] FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude. The revised labeling is the result of a case report in which a human immunodeficiency virus (HIV) variant containing the M184V resistance substitution was documented during Baraclude treatment for chronic hepatitis B virus (HBV) infection in an HIV/HBV co-infected patient who was not simultaneously receiving highly active antiretroviral therapy (HAART).
Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information.
[August 16, 2007 - Letter - Bristol-Myers Squibb]
[July 24, 2007 - Label - Bristol-Myers Squibb]
[February 2007 – Letter – Bristol-Myers Squibb]
[February 2007 – Label – Bristol-Myers Squibb]
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- CellCept (mycophenolate mofetil)
- Audience: Cardiac transplantation healthcare professionals
Indication: Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants
[Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and CellCept to Rapamune (sirolimus) and CellCept at 12 weeks post heart transplantation. The safety and efficacy of CellCept in combination with sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been established.
[February 2007 – Letter – Roche]
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-
- Attention Deficit Hyperactivity Disorder (ADHD) drug products
- Audience: Neuropsychiatric, pediatric and other healthcare professionals
[Posted 02/21/2007] FDA notified healthcare professionals that the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) have been directed to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines and to advise them of precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers each time a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events.
An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).
[February 21, 2007 - Drug Information Page - FDA]
[February 21, 2007 - News Release - FDA]
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- Xolair (omalizumab)
- Audience: Pulmonary healthcare professionals, asthmatic patients
Indications and Usage: for treatment of adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.
[UPDATE 07/02/2007] Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for Xolair was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for Xolair is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, Xolair should only be administered to patients in a healthcare setting under direct medical supervision. Patients should be observed for an appropriate period of time following each Xolair injection.
[Posted 02/21/2007] FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (omalizumab). Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis—with onset two to 24 hours or even longer—after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose. Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the Xolair label and provide a MEDICATION GUIDE for patients to strengthen the existing warning for anaphylaxis.
[July 2, 2007 - Healthcare Professional Information - FDA]
[July 2, 2007 - Prescribing Information - Genetech]
[July 2, 2007 - MEDICATION GUIDE - Genentech]
[February 21, 2007 - Drug Information Page - FDA]
[February 21, 2007 - News Release - FDA]
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- Avandia (rosiglitazone maleate)
Avandamet (rosiglitazone maleate and metformin hydrochloride)
Avandaryl (rosiglitazone maleate and glimepiride)
- Audience: Endocrinologists, other healthcare professionals, consumers
Indication: Treatment of type 2 diabetes mellitus
[Posted 02/20/2007] Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. At GSK's request, an independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone.
[February 2007 - Letter - GSK]
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-
- Unsafe, Misrepresented Drugs Purchased Over the Internet:
Ambien (zolpidem tartrate) , Xanax (alprazolam), Lexapro (escitalopram oxalate), and Ativan (lorazepam)
- Audience: Consumers, healthcare professionals
[Posted 02/16/2007] FDA informed consumers and healthcare professionals regarding the possible dangers of buying prescription medications online. Individuals who ordered Ambien, Xanax, Lexapro, and Ativan over the internet received a product that contained haloperidol, a powerful anti-psychotic drug. Several consumers experienced difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product and had to seek emergency medical treatment. Haloperiodol can cause muscle stiffness, spasms, agitation and sedation. Taking medication that contains an active ingredient other than what is prescribed by qualified healthcare professionals is generally unsafe. FDA urges consumers to review the FDA website for additional information prior to making purchases of medications over the internet (http://www.fda.gov/buyonline/).
[February 16, 2007 - News Release - FDA]
-
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-
- Erythropoiesis Stimulating Agents:
Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa)
- Audience: Oncologists, nephrologists, other healthcare professionals
[UPDATE 03/09/2007] FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs. These research studies were evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. FDA believes these new concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have changed the full prescribing information for these drugs to include a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs.
[Posted 02/16/2007] FDA notified healthcare professionals of the results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this study, patients received either Aranesp, an ESA, according to the approved dosing regimen or placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other ESAs. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.
[March 09, 2007 - Public Health Advisory - FDA]
[March 09, 2007 -
News Release - FDA]
[March 09, 2007 -
Questions and Answers - FDA]
[February 16, 2007 - Drug Information Page - FDA]
[March 2007 - Label for Epogen/Procrit - Amgen]
[March 2007 - Label for Aranesp - Amgen]
Previous MedWatch Alerts:
[January 27, 2007]
[November 17, 2006]
-
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- Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq)
- Audience: Pediatric healthcare professionals, consumers
[Posted 02/13/2007] FDA issued a Public Health Notification to inform health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq). Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted.
Because vaccine adverse events are not always reported to FDA, there may be additional cases of intussusception following vaccination of which we are unaware. This information is important in helping FDA and CDC assess whether RotaTeq may be associated with an increased risk of intussusception and, if so, to what degree. Healthcare professionals and others are encouraged to report any cases of intussusception or other serious events that may be associated with the use of RotaTeq to the Vaccine Adverse Event Reporting System (VAERS). Parents should contact their child’s doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception.
[February 13, 2007 – Public Health Notification – FDA]
[January 2007 – Label – Merck]
[January 2007 – Patient Product Information – Merck]
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- Ketek (telithromycin)
- Audience: Infectious disease and pulmonary specialists, other healthcare professionals, consumers
[UPDATE 03/26/2007] Sanofi-Aventis issued a "Dear Healthcare Professional" letter.
[Posted 02/12/2007] FDA and Sanofi-Aventis notified healthcare professionals of revisions to the prescribing information, including a BOXED WARNING and a new Patient Medication Guide, for the antibiotic Ketek. Two of the three previously approved indications, acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, were removed from the prescribing information because the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity. In addition, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances. The BOXED WARNING states that Ketek is contraindicated in patients with myasthenia gravis. The Patient Medication Guide, which must be distributed to all patients, informs them about the risks of the drug and how to use it safely.
[March 2007 – Letter – Sanofi-Aventis]
[February 12, 2007 – Press Release – FDA]
[February 12, 2007 – Label –Sanofi-Aventis]
[February 12, 2007 – Medication Guide – Sanofi-Aventis]
[February 12, 2007 – Drug Information Page – FDA]
Previous MedWatch Alerts
[June 29, 2006]
[January 20, 2006]
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-
- HoMedics Heating Pads
- Audience: Consumers and Healthcare professionals
[UPDATE 07/12/2007] FDA advises consumers to stop using heating pads manufactured by HoMedics, Inc. because the products may cause burns or fires. Consumers should return the heating pads to the place of purchase immediately. See the FDA "Advice For Patients" page below for a list of the product model numbers affected by the recall.
[UPDATE 03/19/2007] Recall classified by FDA as Class I.
[Posted 02/09/2007] HoMedics and FDA notified consumers and healthcare professionals of a nationwide recall of 292,108 heating pads produced by HoMedics and shipped within the United States in 2001 and 2002. Some of the heating pads contain an inadequate connector crimp, which can lead to a high resistance connection that may generate excessive heat. This can pose a risk of minor or first degree burn injuries, fire or damage to the heating pad itself or to materials (like bedding and furniture) that come in contact with the pad. Consumers who have any of the heating pads should discontinue use of the product and return it immediately to the retailer of purchase for a full refund. See recall notice for specific HoMedics Heating Pad Model Numbers.
[July 25, 2007 - Questions and Answers - FDA]
[July 12, 2007 - Advice for Patients - FDA]
[March 19, 2007 - Recall Notice - FDA]
[February 09, 2007 – Press Release – HoMedics]
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- Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL Medication Errors
- Audience: Pharmacists, neonatology/pediatric healthcare professionals
[Posted 02/07/2007] Baxter and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL. Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin products use blue as the prominent background color on their labels.
[February 06, 2007 – Letter – Baxter]
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- Custom Ultrasonics System 83 Plus Washer/Disinfector
System 83 Plus Mini-flex Washer/Disinfector
- Audience: Hospital risk managers, nursing supervisory staff
[UPDATE 02/27/2007] FDA issued a Public Health Notification to further inform hospitals and other user facilities about FDA’s action, and to provide recommendations for facilities currently using the affected products.
[Posted 02/07/2007] FDA informed healthcare professionals that Custom Ultrasonics agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System 83 Plus Mini-flex Washer/Disinfector, used to wash and disinfect flexible endoscopes, until it brings its manufacturing methods and controls into compliance with FDA requirements. Endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life threatening infections. FDA advised health care providers to discontinue using these products, using an alternative device or following appropriate protocols to manually wash and disinfect the device.
[February 27, 2007 – Public Health Notification – FDA]
[February 07, 2007 – News Release – FDA]
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- Topical Anesthetic Drugs for Cosmetic Procedures
- Audience: Consumers, healthcare professionals
[Posted 02/06/2007) FDA informed consumers and healthcare professionals of the potential hazards of using skin numbing products containing topical anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. Numbing products are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain, burning and itching due to a variety of medical conditions. FDA has approved many of these products for these uses. Some of these products must be prescribed by a doctor, others may be purchased without a prescription. FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of the numbing product to their skin, which can cause life-threatening side effects and death. If a skin numbing product is prescribed or recommended for a procedure, consumers should do the following:
- use a topical anesthetic approved by the FDA.
- use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that will relieve pain.
- ask for instructions from your doctor on how to safely use the topical anesthetic.
[February 06, 2007 – Public Health Advisory – FDA]
Previous MedWatch alert
[December 06, 2006]
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- Vapotherm 2000i (Respiratory Gas Humidifier System)
- Audience: Neonatologists, respiratory healthcare professionals, hospital clinical managers
[Posted 02/01/2007] FDA notified healthcare professionals of the reintroduction of the 2000i Respiratory Gas Humidifier System. This system was recalled in 2005 due to possible contamination with Ralstonia spp. cultures. FDA noted that premature neonates, immunocompromised patients and those with underlying respiratory illness (such as cystic fibrosis) or malignancy may be at particularly high risk for infection if exposed to breathing gases from a contaminated Vapotherm device. FDA issued recommendations for the steps to take before using the reintroduced device.
[February 01, 2007 – Public Health Notification – FDA]
Previous MedWatch alert
[December 20, 2005]
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-
- Lucentis (ranibizumab injection)
- Audience: Ophthalmological healthcare professionals
Indication: Treatment of patients with neovascular (wet) age-related macular degeneration
[Posted 02/01/2007] Genentech informed healthcare professionals of preliminary safety information from a planned interim analysis in an ongoing study (SAILOR) which confirmed the higher incidence of stroke in the 0.5 mg dose group compared to the 0.3 mg dose group (1.2% versus 0.3%, respectively; P=0.02) of patients with neovascular (wet) age-related macular degeneration who received intravitreal Lucentis. The rates of stroke for both dose groups are lower than the rates seen in the controlled clinical trials and included in the approved labeling. The planned frequency of dosing was not the same as that described in the approved labeling. This comparison was one of many made during this interim analysis.
[January 24, 2007 – Letter – Genentech]
[June 30, 2006 - Label - Genentech]
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-
- Aranesp (darbepoetin alfa)
- Audience: Oncological healthcare professionals
[Posted 01/27/2007] Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. The study also showed higher mortality in patients receiving Aranesp. Aranesp is approved for the treatment of patients with anemia caused by the chemotherapy treatment of the malignant disease and should only be used in accordance with its approved product labeling.
[January 26, 2007 – Letter – Amgen]
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- Liviro3 Dietary Supplement Recall
- Audience: Consumers, healthcare professionals
[Posted 01/25/2007] FDA and Ebek, Inc. notified healthcare professionals and consumers of a voluntary nationwide recall of the company's dietary supplement because the product contains tadalafil, a drug used to treat erectile dysfunction. Liviro3 is not approved by FDA to treat this condition. Tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Consumers who have Liviro3 should stop using it immediately and contact their physician if they experience any problems that may be related to taking this product.
[January 19, 2007 – Press Release – Ebek]
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-
- Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal
- Audience: Surgeons, surgical service personnel and hospital risk managers
[UPDATE 02/01/2007] Recall classified as Class I because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death. Customers should stop using the recalled product and return unused units to the company.
[Posted 01/12/2007]
Davol/Bard and FDA notified healthcare professionals of an expanded recall and withdrawal of Large Oval and Large Circle patches. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas.
[January 31, 2007 – Recall Notice – FDA]
[January 10, 2007 – Letter – Davol/Bard]
Previous MedWatch Alert:
[March 31, 2006]
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- Cough and Cold Medications in Children Less Than Two Years of Age
- Audience: Pediatric and primary care healthcare professionals and patients
[Posted 01/12/2007] The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years.
[January 12, 2007- MMWR Weekly - CDC]
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- Tamiflu (oseltamivir phosphate)
- Audience: Pediatric and primary care healthcare professionals and patients
Indication: Treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days.
[Posted 01/04/2007] Roche notified healthcare professionals of a correction to a Dear Healthcare professional letter issued on November 13, 2006. The original letter referenced changes to the PRECAUTIONS Section of prescribing information for Tamiflu about post marketing reports of self-injury and delirium with the use of Tamiflu in patients with influenza. The prescribing information that accompanied the letter contained an incorrect dosing chart for the Standard Dosage of Tamiflu Oral Suspension for prophylaxis of influenza in pediatric patients. The chart incorrectly specified twice daily instead of once daily dosing under "Recommended Dose" for 10 days. Healthcare professionals should discard the incorrect version of the package insert included in the November 13, 2006 mailing and refer to the new dosing chart included in the December 26, 2006 letter.
[December 26, 2006 - Letter - Roche]
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