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- Tarceva (erlotinib)
- Audience: Oncological, dermatological and ophthalmological healthcare professionals
[Posted 05/08/2009] OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.
[April, 2009 - Dear Healthcare Professional Letter - OSI - Genentech]
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- Biosite brand Triage Cardiac Panel
- Audience: Emergency care managers, hospital risk managers, laboratory services managers
[Posted 05/08/2009] Biosite and FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by health professionals as an aid in the diagnosis of a heart attack (myocardial infarction).The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have.
Lot #W44467B, shipped as 25 individually pouched devices per kit box, was distributed from January 24, 2009 through February 17, 2009. On April 27, 2009, the company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products.
[May 08, 2009 - Recall Notice - FDA]
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- Testosterone gel products (AndroGel 1% and Testim 1%)
- Audience: Urological and Endocrinological healthcare professionals, pediatricians
[Posted 05/07/2009] FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for secondary exposure.
[May 07, 2009 - News Release - FDA]
[May 07, 2009 - Approval Letter - Androgel - FDA]
[May 07, 2009 - Approval Letter - Testim - FDA]
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- Hydroxycut Products
- Audience: Consumers, healthcare professionals
[Posted 05/01/2009] FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc., because they are associated with serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.
FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplants. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
[May 01, 2009 - Hydroxycut Products page - FDA]
[May 01, 2009 - News Release - FDA]
[May 01, 2009 - Dear Healthcare Professional letter - FDA]
[May 01, 2009 - Consumer Questions and Answers - FDA]
[May 01, 2009 - Health Hazard Evaluation - FDA]
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- Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump
- Audience: Diabetes healthcare professionals, patients
[Posted 05/01/2009] Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.
[April 30, 2009 - Press Release - FDA]
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- Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
- Audience: Cosmetic surgeons, neurologists, consumers
[Posted 04/30/2009] FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.
FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.
FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication.
[April 30, 2009 - Follow-up to the February 8, 2008, Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) - FDA]
Previous MedWatch Alert
[02/08/2008]
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- Libimax
- Audience: Consumers, pharmacists
[Posted 04/29/2009] Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. This product poses a threat to health because tadalafil 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 Libimax 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.
[April 27, 2009 - Press Release - Nature & Health Co.]
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- Personal Care Non-Acetone Nail Polish Remover
- Audience: Dermatologists, ER healthcare professionals
[Posted 04/29/2009] Personal Care Products and FDA notified healthcare professionals of a voluntarily nationwide recall of all lots of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin, 6 fl. oz., UPC 4815592076, because it has the potential to cause chemical burns to the fingers of users.
[April 29, 2009 - Press Release - Personal Care Products]
[April 29, 2009 - Photo of Personal Care Non-Acetone Nail Polish Remover]
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- Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.
- Audience: Consumers, pharmacists
[Posted 04/22/2009] ABC Beauty Supply and FDA notified consumers and healthcare professionals of a recall of 34 dietary supplement products. FDA lab analyses identified undeclared sibutramine, an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that these products pose a threat to consumers because sibutramine 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. See the firm's press release for a list of affected products.
[April 20, 2009 - Press Release - Universal ABC Beauty Supply International]
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- Influend Cough and Cold Products
- Audience: Pharmacists, consumers
[Posted 04/16/2009] ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008 due to the possibility that the products may be superpotent with possible complications ranging from tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension to headaches, dizziness, anxiety, restlessness and nervousness. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
[April 15, 2009 - Recall Notice - ION Labs]
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- Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters
- Audience: Cardiology and cardiovascular healthcare professionals, hospital risk managers
[Posted 04/15/2009] Teleflex Medical and FDA notified healthcare professionals of the Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart. This recall is being conducted because a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.
[April 15, 2009 - Recall Notice - FDA]
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- Ceftriaxone (marketed as Rocephin and generics)
- Audience: Neonatology, infectious disease healthcare professionals, hospital risk managers
[Posted 04/14/2009] FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines. These two in vitro studies were conducted in neonatal and adult plasma to assess the potential for precipitation of ceftriaxone-calcium using varying ceftriaxone and calcium concentrations, including concentrations in excess of those achieved in vivo. Based on the results from these studies, FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients >28 days of age, using the precautionary recommendations noted because the risk of precipitation is low in this population. FDA had previously recommended, but no longer recommends, that in all age groups ceftriaxone and calcium-containing products should not be administered within 48 hours of one another.
[April 14, 2009 - Information for Healthcare Professionals - Ceftriaxone - FDA]
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- ZOLL AED Plus Defibrillator
- Audience: Emergency medical personnel
[Posted 04/09/2009] ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. See the Zoll letter for details.
[April 08, 2009 - Recall Notice - FDA]
[March 31, 2009 - Customer Letter - ZOLL Medical]
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- Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits
- Audience: Hospital Risk Managers, Surgical Services Managers
[Posted 04/03/2009] Tri-State Hospital Supply Corporation and FDA notified healthcare professionals of a class 1 recall of multiple types of Centurion brand disposable trays and kits used for insertion of tubes, catheters and ports, due to package sealing that may effect the sterility of the devices. These products were distributed from November 24, 2008 through January 7, 2009. Distributors and customers were instructed to remove the products from their inventory, inform the company of the number of products in stock and hold the products until the company arranges for their return.
[April 03, 2009 - Recall Notice - FDA]
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- Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
- Audience: Pharmacists, cardiology healthcare professionals, consumers
[Posted 04/01/2009] Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.
[March 31, 2009 - Press Release - Caraco Pharmaceutical Laboratories, Ltd.]
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- Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide
- Audience: Neurosurgical healthcare professionals, hospital risk managers
[Posted 03/27/2009] Medtronic and FDA notified healthcare professionals about a Class I recall of the Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide due to the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery. The ventricular catheters are part of a surgically implanted system that redirects excess fluid from the brain to another part of the body. The recalled product was distributed from April 29, 2004 through December 12, 2008. Patients with questions are encouraged to talk with their physicians. Medtronic sent their customers a recall notice on February 13, 2009 informing them that they should stop using the device, are required to account for each used (implanted) device, are to advise surgeons about the recall, and need to return all unused products to the company.
[March 27, 2009 - Recall Notice - FDA]
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- Propafenone HCL Tablets
- Audience: Cardiology healthcare professionals, patients
[Posted 03/25/2009] FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. The Press Release includes instructions for identifying and returning the affected product.
[March 23, 2009 - Press Release - Watson Pharmaceuticals]
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- Zencore Plus
- Audience: Consumers, healthcare professionals
[Posted 03/20/2009] Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company's supplement product sold under the name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5 inhibitor. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on internet nationwide. Consumers who have this product in their possession should stop using it immediately.
[March 11, 2009 - Press Release - Bodee LLC]
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- Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use
- Audience: Healthcare professionals, patients
[Posted 03/19/2009] The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user. The FDA is working with the Centers for Disease Control and Prevention, professional societies and healthcare organizations to reinforce patient and healthcare provider education about proper and safe use of insulin pens.
[March 19, 2009 - Information for Healthcare Professionals - FDA]
[March 19, 2009 - News Release - FDA]
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- Welch Allyn AED 10 and and MRL JumpStart Defibrillators
- Audience: Emergency services personnel, risk managers, and consumers
[Posted 03/16/2009] FDA and Welch Allen notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007. These devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference. If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. See the Recall Notice for additional instructions and contact information.
[March 16, 2009 - Recall Notice - FDA]
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- Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter
- Audience: Hospital administrators, hospital risk managers, healthcare professionals
[Posted 03/12/2009] FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.
[March 11, 2009 - Recall Notice - FDA]
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- Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc.
- Audience: Emergency room healthcare professionals, pediatricians, hospital risk managers, EMTs
[Posted 03/10/2009] FDA notified healthcare professionals of a Class 1 Recall of specific lots due to complaints received about difficulty inserting: 1) the device used to place the tracheostomy tube into the windpipe (obturator), and/or 2) a suction tube (catheter) into the tracheostomy tube. This problem may require that the tracheostomy tube be removed and replaced. Healthcare professionals and hospitals should remove all remaining affected products from their inventory, and return them for replacement or credit.
[March 09, 2009 - Recall Notice - FDA]
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- Transdermal Drug Patches with Metallic Backings
- Audience: Medical imaging healthcare professionals, hospital risk managers, patients
[UPDATE 03/10/2009] FDA has evaluated the composition of available patches to determine which of them contain metal components and to assure that this information is included in their labeling. Based on current information from this evaluation, FDA is working with the manufacturers of the following patches to update the labeling to include adequate warnings to patients about the risk of burns to the skin if the patch is worn during an MRI scan. It should be noted that some of the drugs listed may have a generic equivalent and more than one size and strength of patch. See the Public Health Advisory for a listing of patches. FDA will update this posting as information becomes available.
[Posted 03/05/2009] FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan. Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.
[March 05, 2009 - Public Health Advisory - FDA]
[March 05, 2009 - News Release - FDA]
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- Metoclopramide-Containing Drugs
- Audience: Healthcare professionals, consumers
[Posted 02/26/2009] FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.
[February 26, 2009 - News Release - FDA]
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- Zonisamide (marketed as Zonegran, and generics)
- Audience: Neurological healthcare professionals
[Posted 02/23/2009] FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary.
[February 19, 2009 - Information for Healthcare Professionals: Zonisamide (marketed as Zonegran, and generics) - FDA]
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- Raptiva (efalizumab)
- Audience: Dermatological healthcare professionals, patients
[UPDATE 04/08/2009] Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva will no longer be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.
[Posted 02/19/2009] FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML. The Public Health Advisory provides recommendations for healthcare providers and patients when treatment with this product is considered.
[April 08, 2009 - Dear Healthcare Professional Letter - Genentech] ![Adobe Acrobat [pdf] file](https://webarchive.library.unt.edu/eot2008/20090511170212im_/http://www.fda.gov/medwatch/images/pdf.gif)
[April 08, 2009 - Dear Patient Letter - Genentech]
[April 08, 2009 - Statement - FDA]
[February 19, 2009 - Public Health Advisory - FDA]
[February 19, 2009 - News Release - FDA]
Previous MedWatch Alert:
[10/17/2008]
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- CellCept (mycophenolate mofetil)
Myfortic (mycophenolic acid)
- Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
[UPDATE 03/24/2009] FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle. Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.
[Posted 02/12/2009] FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.
[March 2009 - Dear Healthcare Professional Letter - Myfortic - Novartis]
[December 2008 - Prescribing Information - Myfortic - Novartis]
[March 2009 - Medication Guide - Myfortic - Novartis]
[January 2009 - Dear Healthcare Provider Letter - CellCept - Roche]
[January 2009 - Dear Pharmacist Letter - CellCept - Roche]
[December 2008 - Medication Guide - CellCept - Roche]
[May 2008 - Prescribing Information - CellCept - Roche]
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- Xigris (Drotrecogin alfa [activated]) - Early Communication about an Ongoing Safety Review
- Audience: Critical care healthcare professionals
[Posted 02/04/2009] FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death in patients with sepsis and baseline bleeding risk factors who received this product. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor vs. only 2 of 53 (3.8%) patients without any bleeding risk factors. The finding by Gentry et al. of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label. Prescribers should refer to the product label for the specific contraindications, warnings, and, precautions and carefully weigh the increased risk of bleeding against the benefits of Xigris.
FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris. FDA will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months.The FDA urges both healthcare professionals and patients to report side effects from the use of Xigris to the FDA's MedWatch Adverse Event Reporting program.
[February 04, 2009 - Early Communication about an Ongoing Safety Review - FDA]
[October 2008 - Xigris Prescribing Information - Eli Lilly]
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- Ethex Corporation Product Recall
- Audience: Pharmacists, Consumers
[UPDATE 02/04/2009] ETHEX Corporation and Ther-RX Corporation expanded the company's previous recall notices to include prescription prenatal vitamin and iron supplement products. See the 02/03/2009 Press Releases for a list of products included in the recall.
[Posted 01/27/2009] FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.
[February 03, 2009 - Press Release - Ethex]
[February 03, 2009 - Press Release - Ther-Rx ]
[January 28, 2009 - Press Release - Ethex]
Previous MedWatch Alerts:
[November 2008]
[October 2008]
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- Venom HYPERDRIVE 3.0
- Audience: Consumers, Pharmacists
[Posted 01/27/2009] FDA notified consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement but containing sibutramine, an undeclared drug product and a controlled substance with risks for abuse or addiction. When present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate, and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke. The product was sold via distributors and in retail stores nationwide and was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743. Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects.
[January 27, 2009 - News Release - FDA]
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- Clopidogrel bisulfate (marketed as Plavix)
- Audience: Cardiovascular healthcare professionals, Pharmacists
[Posted 01/26/2009] FDA notified healthcare professionals that the makers of Plavix have agreed to work with FDA to conduct studies to obtain additional information that will allow a better understanding and characterization of the effects of genetic factors and other drugs (especially the proton pump inhibitors (PPIs)) on the effectiveness of clopidogrel. FDA is aware of published reports that clopidogrel (marketed as Plavix) is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel. These studies should lead to a better understanding about how to optimize the use of clopidogrel. The FDA recognizes the importance of obtaining these data promptly. The drug manufacturers have agreed to a timeline for completing the studies and FDA will review the new information expeditiously and will communicate its conclusions and any recommendations to the public at that time. It could take several months to complete the studies and analyze the results. Until further information is available FDA recommends the following:
• Healthcare providers should continue to prescribe and patients should continue to take clopidogrel as directed, because
clopidogrel has demonstrated benefits in preventing blood clots that could lead to a heart attack or stroke.
• Healthcare providers should re-evaluate the need for starting or continuing treatment with a PPI, including Prilosec OTC,
in patients taking clopidogrel.
• Patients taking clopidogrel should consult with their healthcare provider if they are currently taking or considering taking
a PPI, including Prilosec OTC.
[January 26, 2009 - Early Communication about an Ongoing Safety Review - FDA]
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- Topical Anesthetics
- Audience: Consumers, radiological healthcare professionals, emergency room healthcare professionals, risk managers
[Posted 01/16/2009] FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products.
[January 16, 2009 - Public Health Advisory - FDA]
[January 16, 2009 - Dear Colleague Letter - FDA]
Previous MedWatch Alert:
[02/06/2007]
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