MedWatch - 2005 Safety Information Alerts

HHS Log--links to Department of Health and Human Services website

2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

How to Find a Safety Summary

Click on one of the five categories below, then click on a product to go to the safety summary.

Biologics - Special Nutritional Products and Cosmetics - Drugs and Therapeutic Biologics - Medical Devices

-- or --
Click on "Go To Most Recent" to view the medical product safety summaries in reverse chronological order, starting with the most recent.

Go To Most Recent

The

symbol indicates an Adobe Acrobat file. To read this format, use the free Acrobat Reader software. Select the "Get Acrobat" button to open the Adobe Acrobat download site in a new window browser window.

Biologics (CBER):

Albumin Administration in Critically Ill Patients (posted 05/18/2005)
Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135) (Posted 10/03/2005)
NovoSeven Coagulation Factor VIIa (Recombinant) (Posted 12/01/2005)
Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products (Posted 11/10/2005)

Return to Top

2005 Medical Product Safety Alerts, listed in reverse chronological order (most recent first). For an alphabetical listing, return to the categories on this page. You may also search the entire MedWatch site by keyword at the top of this Safety Information page.

= Adobe Acrobat file (.pdf file), viewed with free Acrobat Reader software. For more information, go to the MedWatch "downloads" page at http://www.fda.gov/MedWatch/getforms.htm



Fraudulent Avian Flu Therapies: Audience: Consumers and all healthcare professionals
[Posted 12/29/2005] FDA notified healthcare professionals and patients that it issued warning letters to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza. FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency is concerned that the use of these products could harm consumers or interfere with conventional treatments.

[December 13, 2005 - Press Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Endologix Powerlink System Delivery Catheters: Audience: Vascular surgery healthcare professionals, OR managers, and hospital risk managers
[Posted 12/20/2005] Endologix and FDA notified healthcare professionals of the voluntary product recall of selected Powerlink System delivery catheters marketed in the U.S., used to deliver minimally invasive treatment for abdominal aortic aneurysms. Endologix initiated the recall as a result of an analysis of three recent reports of tip separation from the catheter sheath inner core during procedures. This action does not include the Powerlink stent grafts that have been implanted in patients or the large diameter 34 mm Powerlink System being evaluated under an investigational device exemption or Powerlink Systems sold outside of the U.S.

[December 14, 2005 - Press Release - Endologix]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Baxter Meridian Hemodialyis (HD) Instrument: Audience: Hemodialysis administrators, nephrologists and other healthcare professionals
[Posted 12/14/2005] The FDA has classified Baxter Healthcare Corporation's Meridian Hemodialyis (HD) Instrument (Product Codes 5M5576 and 5M5576R) as a Class I recall. There have been reports of hemolysis related to kinks in the blood tubing sets used with the Meridian. To date, there have been reports of one death and at least one serious injury, associated with kinking of blood tubing sets routed through both channels of the clips mounted on the front of the Meridian.

This classification does not require the return of Meridian instruments currently in the market. In the September 28, 2005 letter, Baxter directs customers to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the risk of blood tubing kinks.

Baxter also provided labels with the September 28, 2005, customer letter to be affixed to Meridian instruments. The labels clearly display the proper routing of the blood tubing sets. Further, Baxter asks that all care providers be trained on this procedure. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible.

[December 13, 2005 - Press Release - Baxter Healthcare]
[December 19, 2005 - Recall Notice - FDA]
[September 28, 2005 - Firm Recall Notice - Baxter Healthcare]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Methotrexate for Injection (preservative free): Audience: Oncologists, dermatologists, rheumatologists, and other healthcare professionals
[Posted 12/13/2005] FDA and Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot # 859142, exp 09/07, because the active drug substance (“ADS”) used to manufacture Lot # 859142, contained low levels of ethylene glycol. Preservative-free methotrexate is the only formulation that is acceptable for intrathecal administration. Healthcare professionals and suppliers should not distribute these vials and should contact Bedford Laboratories for return instructions. Consumers that have received this product and have questions should contact their physicians.

[December 8, 2005 - Press Release - Bedford Laboratories]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Paroxetine HCl - Paxil and generic paroxetine: Audience: Neuropsychiatric and other healthcare professionals
[Posted 12/08/2005] The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine’s prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.

Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.

[December 8, 2005 - Public Health Advisory - FDA]
[December 7, 2005 - Healthcare Professional Information Sheet [PDF] [HTML] - FDA]
[December 7, 2005 - Patient Information Sheet [PDF] [HTML] - FDA]
[December 2005 - Dear Healthcare Professional Letter - GSK]
[December 2005 - Paxil Label - GSK]
[December 2005 - Paxil CR Label - GSK]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Miracle II Neutralizer and Miracle II Neutralizer Gel by Tedco Inc.: Audience: Healthcare professionals and consumers
[Posted 12/06/2005] The FDA advised consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products manufactured by Tedco, Inc., in West Monroe, Louisiana because the products are bacterially contaminated and have not been proven to be safe and effective. Use of these products could pose a risk of serious adverse events such as infections, particularly in children, the elderly, and individuals with weakened immune systems who are particularly susceptible to illness. A number of stores sell Miracle II Neutralizer and Miracle II Neutralizer Gel, and the products are distributed and sold worldwide and sold via the Internet. The products are packaged in 8 oz, 22 oz, and one-gallon size containers.

[December 06, 2005 - News Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Boston Scientific Stainless Steel Greenfield Vena Cava Filters: Audience: Cardiologists and other healthcare professionals
[UPDATE 01/13/2006] Recall classified as Class 1 recall by FDA.

[Posted 12/06/2005] Boston Scientific Corporation announced that it is voluntarily recalling all Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. All unused devices with a "use before date" prior to March 2007 are to be returned to Boston Scientific (product code M001505010). The total number of devices involved in this recall is estimated at 18,000. There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the filter's delivery system during the implant procedure. If the carrier capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization. Potential adverse events include serious patient injury or death. This recall does not affect vena cava filters that have been implanted in patients.

UPDATE: January 13, 2005 - Recall Notice - FDA

[December 02, 2005 - Press Release - Boston Scientific Corporation]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

NeutroSpec (Technetium [99m Tc] fanolesomab)

Audience: Medical imaging specialists, hospital administrators and risk managers
[UPDATE Posted 12/19/2005] FDA issued a Public Health Advisory to alert patients and health care providers that Palatin Technologies Inc. and Mallinckrodt have agreed to implement an immediate voluntary market suspension due to serious safety concerns, making NeutroSpec unavailable for approved or investigational uses. FDA urges health care providers to discontinue use of existing stocks of NeutroSpec and to contact Palatin Technologies regarding their return. FDA is conducting further investigation into the deaths and adverse events associated with NeutroSpec and is working closely with the manufacturers of the product to evaluate the risks and benefits associated with its use.

[Posted 12/02/2005] Mallinckrodt, Palatin Technologies and FDA notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec [Technetium (99m Tc) fanolesomab], a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium, indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Onset of these events generally occurred within minutes of injection and included two deaths attributed to cardiopulmonary failure within 30 minutes of injection. Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen.

Any patient who receives NeutroSpec should be closely monitored for at least one hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complication. NeutroSpec administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks.

[December 19, 2005 - Public Health Advisory - FDA]
[December 19, 2005 - Drug Information Page - FDA]
[November 30, 2005 - Letter - Mallinckrodt/Palatin]
[July 2004 - Label - Mallinckrodt/Palatin]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Aranesp (darbepoetin alfa): Audience: Hematology/Oncology, Nephrology and other healthcare professionals
[Posted 12/01/2005] Amgen and FDA notified healthcare professionals of revision to the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Aranesp. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with Aranesp. This has been reported predominantly in patients with CRF receiving Aranesp by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.

[November 2005 - Aranesp Letter - Amgen]
[October 2005 - Aranesp Label - Amgen]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Epogen (epoetin alfa)
Procrit (epoetin alfa): Audience: Hematology/Oncology, Nephrology and other healthcare professionals
[Posted 12/01/2005] Amgen, Ortho Biotech and FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Epogen and Procrit. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with these products. This has been reported predominantly in patients with CRF receiving these products by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.

[November 2005 - Epogen Letter - Amgen]
[October 2005 - Epogen Label - Amgen]
[November 2005 - Procrit Letter - Ortho Biotech]
[October 2005 - Procrit Label - Ortho Biotech]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


NovoSeven Coagulation Factor VIIa (Recombinant): Audience: Hematological and other healthcare professionals
[Posted 12/01/2005] Novo Nordisk and FDA notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for NovoSeven, to provide updated safety information on thrombotic and thromboembolic adverse events, based on clinical studies in non-hemophilia patients and on post-marketing safety surveillance. A clinical study in elderly, non-hemophiliac, intracerebral hemorrhage patients indicated a potential increased risk of arterial thromboembolic adverse events with use of NovoSeven, including myocardial ischemia, myocardial infarction, cerebral ischemia and/or infarction.

[November 23, 2005 - Letter - Novo Nordisk]
[October 2005 - Label - Novo Nordisk]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


MBI Distributing, Inc. [Molecular Biologics] Over-The-Counter Eye Drops and Pain-Relieving Drugs: Audience: Consumers, caregivers and healthcare professionals
[Posted 11/30/2005] FDA notified consumers, caregivers, and healthcare professionals that MBI Distributing, Inc. (MBI), also known as Molecular Biologics, an over-the-counter [OTC] drug manufacturer of eye drops and other products will cease manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations. MBI's product line includes eye drops sold under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C, as well as several OTC pain relieving drugs. These products are sold by retailers nationwide.

FDA determined that the firm lacked manufacturing controls to ensure that its eye drops were sterile. FDA has also determined that two of the firm's eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, three of the firm's OTC pain relieving drugs, Biogesic, Bio-Ice, and Bio-Heat, do not provide adequate warnings for their safe use. FDA recommends that consumers, health care providers, and caregivers dispose of the Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C brands of eye drops and the Biogesic, Bio-Ice, and Bio-Heat pain relieving drugs.

[November 29, 2005 - News Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Flomax (tamsulosin HCl): Audience: Ophthalmologists, Urologists, and other healthcare professionals
[Posted 11/22/2005] Boehringer Ingelheim and FDA notified healthcare professionals of revisions to PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for Flomax, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers including Flomax. Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken Flomax or other alpha-1 blockers. If so, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.

[November 2005 - Letter - Boehringer Ingelheim]
[October 5, 2005 - Label - Boehringer Ingelheim]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

GenTeal Gel and GenTeal GelDrops

Audience: Ophthalmologists, other healthcare professionals and consumers
[Posted 11/22/2005] Novartis Ophthalmics and FDA notified healthcare professionals and patients of a voluntary recall due to a lack of sterility assurance of seven lots of two products, GenTeal Gel and GenTeal GelDrops, intended for use to relieve dryness of the eye. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people.

The five lots of GenTeal Gel include about 142,500 tubes that were distributed nationwide from March to November 2004.
The two lots of GenTeal GelDrops include about 12,000 dropper bottles that were distributed nationwide in October 2005.

Test results for GenTeal Gel indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.

[November 16, 2005 - Press Release - Novartis]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Long-acting Beta2-Adrenergic Agonists: Advair Diskus (fluticasone propionate & salmeterol inhalation powder) Foradil Aerolizer (formoterol fumarate inhalation powder) Serevent Diskus (salmeterol xinafoate inhalation powder): Audience: Pulmonologists, other healthcare professionals and consumers
[Posted 11/18/2005] FDA notified manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus to update their existing product labels with new warnings and a Medication Guide for patients to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABA). Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is filled or refilled.

[November 18, 2005 - Public Health Advisory - FDA]
[November 18, 2005 - Drug Information Page - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Diabetisource AC: Audience: Healthcare institutional administrators, healthcare professionals and consumers
[Posted 11/17/2005] FDA and Novartis Nutrition Corporation notified healthcare professionals of a recall of 2,712 bottles of an enteral feeding formula that was incorrectly labeled as Diabetisource AC 1.5 Liter bottles lot 2135L. The affected product was shipped nationwide and is only distributed to healthcare institutional facilities. The bottles contain sodium and calcium caseinate, components of milk. People with an allergy or severe sensitivity to milk may run the risk of a serious or life threatening allergic reaction if they consume this product. Healthcare professionals administering Diabetisource AC to patients who have an allergy or sensitivity to milk should immediately stop using this product.

[November 17, 2005 - Recall Notice - Novartis]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands: Audience: Healthcare risk managers and healthcare professionals
[Posted 11/16/2005] FDA issued a Public Health Notification regarding increased risk for electromagnetic interference in any medical telemetry systems operating in the 460-470 MHz frequency bands after December 31, 2005. This interference could compromise patient safety. In January 2006 the Federal Communications Commission will begin issuing new licenses for mobile radio transmitters to operate in the 460-470 MHz band.

According to tests conducted by the FDA, the transmitters operating under new licenses in this frequency band can interfere with medical telemetry systems. This could lead to lapses in patient monitoring and missed alarm events, putting patients at risk. The anticipated interference will not be limited to urban areas. Any medical facility in the vicinity of a mobile radio could be affected.

[November 16, 2005 - Public Health Notification - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Ortho Evra (norelgestromin/ethinyl estradiol transdermal system): Audience: Reproductive and other healthcare professionals, and consumers
[Posted 11/14/2005] FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.

[November 10, 2005 - News Release - FDA]
[November 10, 2005 - Drug Information Page - FDA]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Amevive (alefacept)

Audience: Dermatologists and other healthcare professionals
[Posted 11/10/2005] Biogen Idec and FDA notified healthcare professionals of revisions to CONTRAINDICATIONS section of the prescribing information for Amevive, indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Amevive should not be administered to patients infected with HIV. Amevive reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients. In addition, other sections of the product labeling were revised to reflect additional safety information.

[October 2005 - Letter - Biogen Idec]
[September 2005 - Label - Biogen Idec]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products: Audience: Endocrinologists and other healthcare professionals, clinical laboratory managers, risk managers and patients
[UPDATE 04/22/2008] Fatal Iatrogenic Hypoglycemia: falsely elevated blood glucose readings with a point-of-care meter due to a maltose-containing intravenous immune globulin product. Following receipt of the index case, FDA conducted an investigation. This review represents the final report of that investigation.

[Posted 11/10/2005] FDA notified physicians, nurses, medical technologists, pharmacists and other healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. There have been reports of the inappropriate administration of insulin and consequent life-threatening/fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. A preliminary listing of U.S. products that may cause glucose test interference is provided.

[April 17, 2008 - Final Report - FDA/CBER/CDRH]
[November 09, 2005 - Important Safety Information - FDA/CBER]
[November 09, 2005 - Reminder Notice - FDA/CDRH]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Avinza (morphine sulfate extended-release capsules): Audience: Pain specialists, other healthcare professionals and consumers
[Posted 11/03/2005] Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to BOXED WARNING, WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION sections of the prescribing information to highlight and strengthen the warning that patients should not consume alcohol while taking Avinza. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on Avinza therapy.

[October 2005 - Letter - Ligand Pharmaceuticals Inc.]
[October 2005 - Label - Ligand Pharmaceuticals Inc.]
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Omron 3-Way Instant Thermometers: Audience: Consumers and Pharmacists
[Posted 11/02/2005] Omron Healthcare Inc. initiated a voluntary recall of certain Omron® 3-Way Instant Thermometers – model numbers MC-600 and MC-600CAN – due to overheating of the tip. Omron had received consumer complaints indicating discomfort during and following use of the thermometers. Consumers who continue using the affected thermometers are at risk of discomfort during use, potentially resulting in redness or even a blister on the skin. Very young children using this device are at an increased risk due to the inability to express themselves and to their difficulty in pulling away from the device held by an adult. The battery-operated, digital thermometers, available through drug stores, the pharmacy sections of food stores and mass merchandise chains, and internet retailers were sold in the United States and Canada between Sept. 19, 2001, and October 21, 2005.

[October 24, 2005 - Press Release - Omron Healthcare Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Salus Corporation Shampoo Caps: Audience: Hospital and Extended Care Facility Risk Managers and supervisory personnel
[Posted 11/01/2005] Salus Corporation dba ICP Medical of Olivette, Missouri, has voluntarily initiated a nationwide recall of all lot numbers of shampoo caps with conditioner because some of the product is contaminated with the bacteria Serratia marcescens. Serratia marcescens has the potential to cause severe and life-threatening illness, especially in those with a compromised immune system. The shampoo caps were manufactured under three brand names: (1) The Salus Corporation dba ICP Medical brand name of CompleteBath (Reorder No. ICP095230); the brand name of ReadyBath, manufactured for Medline Industries, Inc., Mundelein, IL (Reorder No. MSC095230); and the brand name of No-Rinse, manufactured for No Rinse Laboratories, LLC, Centerville, OH (Reorder No. 02000). The shampoo caps were distributed to health care facilities and institutions nationwide through Salus Corporation, Medline Industries, and No Rinse Laboratories. The product can also be purchased through the internet.

[October 31, 2005 - Press Release - Salus Corporation]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Zevalin (ibritumomab tiuxetan): Audience: Hemato-oncologists and other healthcare professionals
[Posted 10/28/2005] Biogen Idec and FDA notified healthcare professionals of revision to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections of the Prescribing Information to describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.

[October 2005 - Letter - Biogen]
[September 2005 - Label - Biogen]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Vapotherm 2000i Respiratory Gas Administration Device: Audience: Neonatologists, Respiratory healthcare professionals and hospital clinical managers
[UPDATE posted 12/20/2005] See update of safety information about Ralstonia spp. associated with Vapotherm Respiratory Gas Administration Device. The FDA continues to collaborate with the CDC to determine the scope of the contamination with Ralstonia spp., and other opportunistic pathogens. Further information is proved in the updated MMWR from CDC.

[Posted 10/27/2005] FDA issued a Preliminary Public Health Notification to inform healthcare professionals of new information about a possible association between the Vapotherm 2000i Respiratory Gas Administration device, used to add moisture and warm breathing gases through a nasal canula in patients receiving supplemental oxygen, and the occurrence of positive Ralstonia spp. cultures. The association was first reported in a MMWR article issued by CDC on October 21, 2005. The new information is described in the web notice at the link below. FDA recommends that providers consider this new information in deciding whether and when to use the Vapotherm device with patients.

[December 20, 2005 - Update: Preliminary Public Health Notification - FDA]
[December 20, 2005 - Morbidity and Mortality Weekly Report - CDC]
[October 27, 2005 - Preliminary Public Health Notification - FDA]
[October 19, 2005 - Morbidity and Mortality Weekly Report - CDC]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Abbott Diabetes Care Blood Glucose Meters: Audience: All healthcare professionals and consumers
[UPDATE 11/04/2005] Class I recall posted.

[Posted 10/27/2005] FDA notified health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia. Hyperglycemia can be a serious and even life-threatening condition and several cases of hyperglycemia have been reported to FDA.

[November 04, 2005 - Recall Notice - FDA]
[October 26, 2005 - News Release - FDA]

Previous Related MedWatch alerts:

May 17, 2005 - LifeScan, Inc. OneTouch Ultra, InDuo and OneTouch FastTake Blood Glucose Meters

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Cylert and generic pemoline products: Audience: Neuropsychiatric healthcare professionals, Pediatricians, Pharmacists and consumers
[Posted 10/24/2005] FDA has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product. Cylert, a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), is considered second line therapy for ADHD because of its association with life threatening hepatic failure. Health care professionals who prescribe Cylert, or any of its generics, should transition their patients to an alternative therapy. Cylert will remain available through pharmacies and wholesalers until supplies are exhausted. No additional product will be available.

[October 24, 2005 - Drug Information page - FDA]
[December 2002 - Label - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Cymbalta (duloxetine hydrochloride): Audience: Neuropsychiatric and other healthcare professionals
[Posted 10/17/2005] Eli Lilly and FDA notified healthcare professionals of revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.

[October 05, 2005 - Letter - Eli Lilly]
[September 2005 - Label - Eli Lilly]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Boston Scientific ENTERYX Procedure Kits and Injector Single Packs: Audience: Surgeons, Gastroenterologists, other healthcare professionals, and patients
[Posted 10/17/2005] FDA and Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with ENTERYX, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of ENTERYX into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of all ENTERYX Procedure Kits and ENTERYX Injector Single Packs from commercial distribution. Physicians should stop injecting ENTERYX immediately and follow the manufacturer’s procedures for returning unused product. FDA also provided recommendations on avoiding future occurrences and advice for patients.

[October 14, 2005 - Preliminary Public Health Notification - FDA]
[October 17, 2005 - Advice for Patients - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135): Audience: Neurological and other Healthcare Professionals, and Consumers
[Posted 10/03/2005] FDA and CDC notified consumers and health care providers of five reports of Guillain Barre Syndrome following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature. Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization. Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter.

[September 30, 2005 - News Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Strattera (atomoxetine): Audience: Neuropsychiatric and other Healthcare Professionals, and Consumers
[Posted 09/29/2005] The FDA directed Eli Lilly and Company (Lilly), the manufacturer of Strattera (atomoxetine), to revise the prescribing information to include a boxed warning and additional warning statements that alert health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication. FDA also informed Lilly that a Patient Medication Guide (MedGuide) should be provided to patients when Strattera is dispensed. The MedGuide advises patients of the risks associated with and precautions that can be taken when Strattera is dispensed. Further, pediatric patients being treated with Strattera should be closely observed for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

[September 29, 2005 - Public Health Advisory - FDA]
[September 29, 2005 - Press Release - FDA]
[September 29, 2005 - Drug Information Page - FDA]
[September 29, 2005 - Healthcare Professional Information Sheet [PDF] [HTML] - FDA]
[September 29, 2005 - Patient Information Sheet [PDF] [HTML] - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Fluorouracil Injection 50mg/mL, (500 mg/10mL Single Dose Vial): Audience: Oncologists, pharmacists, and other healthcare professionals
[Posted 09/27/2005] American Pharmaceutical Partners, Inc. and FDA notified healthcare professionals about a nationwide recall of Fluorouracil Injection 50 mg/mL (500 mg/10ml Single Dose Vial) because of the potential for invisible glass particles containing silica and aluminum in vials of the product. The company states that only Product code 101710 is susceptible to this type of glass breakdown.

[September 2005 - Recall Notice - FDA]
[September 2005 - Product Recall - American Pharmaceutical Partners, Inc.]
[September 2005 - Dear Healthcare Professional Letter - American Pharmaceutical Partners, Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Paxil (paroxetine HCL) Paxil CR Controlled-Release Tablets: Audience: Neuropsychiatric and other healthcare professionals
[Posted 09/27/2005] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets to describe the results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants [OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.
[September 2005 - Dear Healthcare Professional letter - GlaxoSmithKline]
[September 2005 - Paxil Label - GlaxoSmithKline]
[September 2005 - Paxil CR Label - GlaxoSmithKline]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Toprol-XL (metoprolol succinate) extended release tablets Topamax (topiramate) tablets Tegretol (carbamazepine) Tegretol-XR (carbamazepine extended-release)
: Audience: All healthcare professionals
[UPDATE November 10, 2005] Letters from Novartis Pharmaceuticals Corporation added below
[UPDATE September 30, 2005] Letters from Ortho-McNeil Neurologics, Inc. added below

[Posted 09/26/2005] AstraZeneca and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between Toprol-XL (metoprolol succinate) extended release tablets, indicated for the treatment of hypertension, long-term treatment of angina pectoris, and heart failure NYHA Class II or III, and Topamax (topiramate), a product of Ortho-McNeil Neurologics, Inc, indicated for the treatment of epilepsy and migraine prophylaxis. There have also been reports of medication errors involving confusion between Toprol-XL and Tegretol or Tegretol-XR (carbamazepine), products of Novartis Pharmaceuticals Corporation, indicated for the treatment of complex partial seizures, generalized tonic-clonic seizures, and trigeminal neuralgia. These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR, and vice versa, some of them leading to adverse events.

[October 2005 - Dear Healthcare Professional Letter - Novartis]
[October 2005 - Dear Pharmacist Letter - Novartis]

[September 2005 - Dear Healthcare Professional Letter - Ortho-McNeil Neurologics, Inc.]
[September 2005 - Dear Pharmacist Letter - Ortho-McNeil Neurologics, Inc.]

[September 22, 2005 - Dear Healthcare Professional Letter - AstraZeneca]
[September 22, 2005 - Dear Pharmacist Letter - AstraZeneca]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Injectable Products made by Central Admixture Pharmacy Service (CAPS) of Lanham, Maryland

Audience: Audience - Hospital Risk Managers, Pharmacists and Nursing Supervisory Staff
FDA is notifying healthcare professionals and hospitals about a product recall involving all injectable products manufactured by Central Admixture Pharmacy Services, Inc. of Lanham, Maryland (CAPS) due to concerns regarding the sterility of these injectable products. CAPS distributed the affected injectable products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. Gram negative rods have been identified in two lots of Cardioplegia solution manufactured by CAPS. Non-sterility of injectable products could represent a serious hazard to health that could lead to life-threatening injuries and death.

The following products distributed up to September 16, 2005, are affected by this action:

Cardioplegia solutions including: Cardioplegia, Cold Cardioplegia, Warm Cardioplegia, Blood Cardioplegia 1, Blood Cardioplegia 2, Cardioplegia Base 1, Cardioplegia Base 2, Cardioplegia Base, Cardioplegia Reperfusion, Cardioplegia High Potassium, Cardioplegia Low Potassium, Cardioplegia #1, Cardioplegia #2 Cardioplegia #3; Maintenance Cardioplegia, Enriched Cardioplegia, Cardioplegia Hot Shot, Cardioplegia Base Enriched
Oxytocin injectable products including: Oxytocin Infusion, Oxytocin 20 units, Oxytocin 30 units, Oxytocin D5 ½ NS, Oxytocin in Lactated Ringers
Promethazine
Magnesium-containing injectable products including: Magnesium 1 GM, Magnesium 2 GM, Magnesium Sulfate 2 GM, Magnesium 4 GM, Hydration-Magnesium in D5W, Magnesium Infusion, Magnesium in Lactated Ringers
Heparin Replacement
Antibiotic Irrigation Bag and Bottle
Bupivicaine 0.25 % and 0.5%, Pain Bags (Bupivicaine 0.25 %)
Dialysate solutions including: Citrate Dialysate, Heparin Dialysate, Pediatric Dialysate, Hydration Dialysate #1, Hydration Dialysate #2, CRRT Dialysate, CVVHD (Dialysate) 300, CVVHD (Dialysate) 342, CVVHD Pediatric Formula (Normocarb), CVVHD Formalin #1, CVVHD Formalin #2, CVVHD Formalin #3, CVVHD Non-Standard, CVVHD D5W, CVVHD ½ NS, CVVHD NS
Total Parenteral Nutrition (TPN) products including: TPN-Day, TPN-Day 1 Neonatal Stock Solution
Diltiazem (Cardizem)
Norepinephrine (Levophed)
Cefazolin

Although CAPS has directly notified known hospital customers of the recall, hospitals, physicians, and health care workers are urged to examine their supplies for any CAPS of Lanham, MD injectable products and immediately discontinue their use and quarantine the products.

[September 17, 2005 - Recall Notice - CAPS of Lanham, MD]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


BioMerieux VeriCal Calibrator Set: Audience: Laboratory supervisory personnel and healthcare professionals

[UPDATE 10/14/2005] Class I recall notice added below

[Posted 09/16/2005] BioMerieux and FDA notified healthcare professionals of a recall of VeriCal Calibrator Set, used to calibrate the Prothrombin Time (PT) and Activated Partial Thromboplastin Times (APTT) on bioMerieux instrument platforms. This recall only impacts INR determinations derived from Prothrombin Tim (PT) results on the following instrument platforms: MDA Coag-A-Mate MTX and Coag-A-Mate MAX. The recall is due to the mis-assignment of ISI values associated with VeriCal use. These calibrated ISI values are currently provided on Simplastin HFT and Simplastin L product labeling. The VeriCal labeling currently contains PT time in seconds and is being revised to include ISI assignment for specified reagents. The product recall notice offers detailed recommendations for action by laboratory personnel using these products.
[November 14, 2005 - Recall Notice - FDA]
[August 31, 2005 - Recall Notice - BioMerieux Inc.]

Related MedWatch safety alert: [May 16, 2005]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) NovoLog (insulin aspart [rDNA origin] injection): Audience: Pharmacists and other healthcare professionals
[Posted 09/14/2005] Novo Nordisk Incorporated and FDA notified pharmacists of an initiative implemented to help prevent dispensing errors. To facilitate the dispensing of the correct product, color branded labeling has been introduced for NovoLog Mix 70/30, a premixed insulin analog, and NovoLog, a rapid-acting insulin analog. The previous box for NovoLog Mix 70/30 was white with a blue band. The current packaging for NovoLog Mix 70/30 is very similar and remains white with a blue band. The packaging for NovoLog previously was also white with a blue band. The current packaging is now white with an orange band. It is important that all pharmacists carefully distinguish insulin formulations by name and NDC number when dispensing.

[August 26, 2005 - Letter - Novo Nordisk Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Erbitux (cetuximab): Audience: Oncologists and other healthcare professionals
[Posted 09/14/2005] ImClone Systems Incorporated, Bristol-Myers Squibb Company and the FDA notified healthcare professionals of changes to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Erbitux, indicated for the treatment of epidermal growth factor receptor (EGFR) expressing metastatic colorectal carcinoma. The WARNINGS and DOSAGE AND ADMINISTRATION sections have been revised to notify healthcare providers about specific recommendations on observation periods following Erbitux infusion. In addition, the PRECAUTIONS and ADVERSE REACTIONS sections have been revised to discuss results seen in Erbitux clinical trials regarding an increased incidence of hypomagnesemia and recommendations for electrolyte monitoring.
[September 13, 2005 - Letter - ImClone Systems Incorporated and Bristol-Myers Squibb Company]
[August 2005 - Label - ImClone Systems Incorporated and Bristol-Myers Squibb Company]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Herceptin (trastuzumab)

Audience: Oncologists, cardiologists, and other healthcare professionals
[Posted 08/31/2005] Genentech and FDA notified healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab), obtained from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a randomized, Phase III trial that was conducted in 2043 women with operable, HER2 overexpressing breast cancer (IHC 3+ or FISH+). This study demonstrated a significant increase in cardiotoxicity in patients who were randomized to the Herceptin-containing arm as compared to patients who received chemotherapy alone.

Preliminary analysis of safety data from Study NSABP B-31 and the North Central Cancer Treatment Group (NCCTG) study (N9831) revealed a statistically significant increase in the 3-year cumulative incidence of New York Heart Association Class III and IV congestive heart failure and cardiac death observed in patients who received the Herceptin-containing regimen (4.1%) compared with control (0.8%). There were no cardiac deaths observed in patients who received the Herceptin-containing regimen and one cardiac death was observed in the control arm. Final analysis of the cardiac safety data collected in Studies NSABP B-31 and NCCTG N9831 is ongoing.

[August 2005 - Letter - Genentech]
[February 2005 - Label - Genentech]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Alcohol-Free Mouthwash and Hygiene Kits by Medline: Audience: Risk managers and hospital and long term care nursing supervisory staff
[Posted 08/29/2005] Medline and FDA notified healthcare professionals about a nationwide recall of Alcohol-Free Mouthwash and Hygiene Kits containing mouthwash because of potential contamination with Burkholderia cepacia. People who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. The product was distributed to hospitals, medical centers, and long term care facilities nationwide. There is no known distribution through retail sales. The CDC has confirmed hospital illness associated with the use of the affected mouthwash in Texas and Florida.

[August 29, 2005 - Notice - FDA]
[August 29, 2005 - Firm Press Release - Medline]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Trypan Blue 0.06% Ophthalmic Solution: Audience: Ophthalmologists, other healthcare professionals, and consumers
[Posted 08/29/2005] Custom RX Compounding Pharmacy and FDA notified ophthalmologists, other healthcare professionals, and consumers about a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution, intended for use in the eyes during cataract surgery, because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The product was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, the District of Columbia, and Pennsylvania. The recall includes, but may not be limited to the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17.

[August 26, 2005 - Press Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Prisma Continuous Renal Replacement System: Audience: Nephrologists, other healthcare professionals and consumers
[UPDATE Posted 03/01/2006] The August 2005 Preliminary Public Health Notification was updated with additional safety information.

[Posted 08/19/2005] Gambro Dasco S.p.A notified healthcare professionals and consumers of a safety alert for the Prisma continuous renal replacement system (all catalog numbers). Gambro Dasco has become aware of several serious injuries and deaths resulting from excessive ultrafiltration (fluid being removed from the patient’s body). This problem can occur when the user does not address the cause of the “Incorrect Weight Change Detected” alarm. This alarm should never be overridden without first identifying and removing the cause of the alarm. The device remains appropriate for use when these directions are followed.
[February 27, 2006 - FDA Updated Public Health Notification - FDA]
[August 23, 2005 - Preliminary Public Health Notification - FDA]
[August 16, 2005 - Press Release - Gambro Dasco S.p.A.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Isotretinoin - Accutane and generic isotretinoin: Audience: Dermatological, other healthcare professionals and patients
[Posted 08/12/2005] FDA notified healthcare professionals and patients of the approval of a strengthened risk management program, called iPLEDGE, for Accutane and generic isotretinoin. The strengthened program requires registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense and use Accutane. In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin..

[August 12, 2005 Public Health Advisory - FDA]
[August 12, 2005 Press Release - FDA]
[August 12, 2005 Drug Information Page - FDA]
[August 12, 2005 Healthcare Professional Information Sheet [PDF] [HTML] - FDA]
[August 12, 2005 Patient Information Sheet [PDF] [HTML] - FDA]
[August 12, 2005 Label - Roche]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Metallic Tracheal Stents in Patients with Benign Airway Disorders: Audience: Pulmonary Medicine and other healthcare professionals
[Posted 08/02/2005] FDA issued a Public Health Notification to alert healthcare professionals to serious complications associated with the use of metallic tracheal stents in patients with benign airway disorders, and to recommend specific actions to prevent or minimize the problem. This notification includes all covered and uncovered metallic tracheal stents. These complications include obstructive granulation tissue, stenosis at the ends of the stent, migration of the stent, mucous plugging, infection, and stent fracture. This notification focuses on patients with benign airway disorders because use of metallic stents in this patient population may preclude them from receiving future alternative therapies (such as tracheal surgical procedures or placement of silicone stents) after a metallic stent is removed.

[August 02, 2005 - Public Health Notification - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Perrigo Infants' Oral Drops Containing Enclosed Syringe

Audience: Pharmacists, Pediatricians and other healthcare professionals
[Posted 08/02/2005] Perrigo and FDA notified healthcare professionals and consumers of the recall of all lots of concentrated infants’ drops that are packaged with a dosing syringe bearing only a “1.6 mL” mark containing:

1. acetaminophen,
2. acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl, or
3. dextromethorphan HBr, and pseudoephedrine HCl.

The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing. The following products are being recalled:

* Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
* Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
* Cherry Flavor Cough and Cold Infant Drops (0.5oz)
* Cherry Flavor Decongestant and Cough Infant Drops (0.5oz)

[August 01, 2005 - Talk Paper - FDA]
[July 29, 2005 - Press Release - Perrigo]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Counterfeit "Lipitor" Sold in the United Kingdom: Audience: Consumers and healthcare professionals
[Posted 08/02/2005] FDA alerted U.S. residents to the recent recall of a batch of counterfeit "Lipitor" (atorvastatin) sold in the United Kingdom (U.K.). The medicine is used to treat high cholesterol. The counterfeit Lipitor 20mg tablets were recalled in the U.K. on July 28, 2005. Health authorities in the U.K. stated that initial results of tests performed on the counterfeit drugs do not indicate that this product poses an immediate risk to patients. Some U.S. residents may have obtained prescription drugs from the U.K. through on-line or storefront operations that do not supply legitimate, FDA-approved products, or through state-run drug importation programs that facilitate the purchase of unapproved foreign drugs. Consumers who purchase drugs through these arrangements may have received these counterfeit products. U.S. patients who have the identified U.K. drugs should stop using them and should consult their physician or pharmacist if they have any questions or concerns.

[July 29, 2005 - News Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

D-TRON adapters, used with D-TRONplus Insulin Pump: Audience: Endocrinologists, pediatricians and other healthcare professionals
[Posted 08/01/2005] Disetronic Medical Systems and FDA notified healthcare professionals and patients about a nationwide recall of D-TRON adapters, used with the D-TRONplus insulin pump, because they can potentially over-deliver a maximum amount of up to 1.8 I.U. of insulin. Use of these recalled adapters may pose a potential life-threatening situation to certain children using the pump. Other users who are insulin sensitive may also be at increased risk. The root cause of this issue is a sporadic failure of a valve inside the D-TRON adapter to close completely, which can result in a potential over-delivery of a maximum amount of up to 1.8 I.U. of insulin.

[July 29, 2005 - News Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Baxter Healthcare Colleague Volumetric Infusion Pumps: Audience: Hospital Nursing Administrators, Risk Managers and other healthcare professionals
[Posted 07/21/2005] Baxter Healthcare Corporation and FDA notified healthcare professionals of a Class I recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R. In addition to the shut-down problem, the device may exhibit two additional failure modes: 1) Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion; 2) Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered "on" can result in a failure code, requiring the infusion to be restarted. These failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to mitigate any disruptions of infusions of life-sustaining drugs or fluids. Approximately 255,000 Colleague Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States.

[September 19, 2005 - Recall Notice - FDA]
[July 22, 2005 - Recall Notice - FDA]
[July 21, 2005 - News Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Raptiva (efalizumab): Audience: Dermatological and other healthcare professionals
[Posted 07/20/2005] Genentech and FDA revised the WARNINGS, ADVERSE REACTIONS sections and Patient Information Sheet for RAPTIVA (efalizumab), indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Healthcare professionals and patients were informed about reports of immune-mediated hemolytic anemia and warnings regarding postmarketing reports of thrombocytopenia and serious infections including necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment.

[July 15, 2005 - Letter - Genentech]
[June 2005 - Label - Genentech]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Mifeprex (mifepristone): Audience: Reproductive healthcare professionals
[Posted 07/19/2005] Danco Laboratories and FDA have revised the BOXED WARNING and WARNINGS sections of the Prescribing Information, the Medication Guide and Patient Agreement to inform healthcare professionals of four cases of septic deaths in the United States, all reported from California, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection. All providers of medical abortion and their patients need to be aware of the risks of sepsis.

[July 19, 2005 - Public Health Advisory - FDA]
[July 19, 2005 - Drug Information Page - FDA]
[July 19, 2005 - Questions and Answers - FDA]
[July 19, 2005 - Letter - Danco Laboratories]
[July 19, 2005 - Label - Danco Laboratories]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Guidant Corporation Cardiac Pacemakers: Audience: Cardiologists/cardiovascular healthcare professionals
[UPDATE 07/25/2005] The FDA has classified Guidant's action as a Class I recall because of a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

[Posted 07/19/2005] Guidant notified physicians and patients of new safety information for certain models of cardiac pacemakers manufactured between November 25, 1997 and October 26, 2000. A hermetic sealing component used in these devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life. The clinical behaviors associated with this failure mode can result in serious health complications. Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization. Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing. Physicians should consider the unique needs of individual patients and the specific technical recommendations set forth in the July 18, 2005 physician communication. Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients and advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

[July 27, 2005 - Recall Notice - FDA]
[July 22, 2005 - Press Release - FDA]
[July 18, 2005 - Press Release - Guidant]
[July 18, 2005 - Physician Communication - Guidant]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Natrecor (nesiritide): Audience: Cardiologists/cardiovascular healthcare professionals
[Posted 07/18/2005] Scios and FDA notified healthcare professionals about the recommendations of an expert panel of cardiology and heart failure clinicians with regard to NATRECOR (nesiritide). With respect to recent questions raised about worsened renal function and mortality, the panel provided a consensus statement on each issue, provided advice on the ongoing and planned clinical development program, made recommendations about the appropriate use of the drug and recommeded an educational campaign to ensure that clinicians understand when the use of NATRECOR is appropriate and when it is not appropriate.

[July 13, 2005 - Letter - Scios] PDF Format

Previous 2005 MedWatch Safety Alert

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators: Audience: Cardiologists and other healthcare professionals
[UPDATE December 29, 2005] FDA issued an update to the July and October, 2005, Preliminary Public Health Notification. The updated PPHN provides numbers of deaths and serious injuries for the three devices as of December 12, 2005. FDA's recommendations have not changed.

[Posted 07/18/2005] FDA issued a Preliminary Public Health Notification and advice for patients for Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators to provide clinicians with current information and guidance concerning malfunctions occurring with these devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005. The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. The affected devices are:
VENTAK PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004.

[December 28, 2005 UPDATE- Preliminary Public Health Notification - FDA]
[October 13, 2005 UPDATE- Preliminary Public Health Notification - FDA]
[July 18, 2005 - Recall Notice for Ventak PRIZM 2 - FDA]
[July 18, 2005 - Recall Notice for CONTAK RENEWAL and CONTAK RENEWAL 2 - FDA]
[July 14, 2005 - Preliminary Public Health Notification - FDA]
[July 15, 2005 - Advice for Patients - FDA]

Previous 2005 MedWatch Safety Alert

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Fentanyl Transdermal (Skin) Patch: Audience: Healthcare professionals, patients and their caregivers
[Posted 07/15/2005] FDA issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product. Some patients and health care providers may not be fully aware of the dangers of this very strong narcotic painkiller. The directions for using the fentanyl skin patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl. These directions are available on the Drug Information Page linked below.

[July 15, 2005 - Public Health Advisory - FDA]
[July 15, 2005 - Healthcare Professional Sheet [PDF] [HTML] - FDA]
[July 15, 2005 - Patient Information Sheet [PDF] [HTML] - FDA]
[July 15, 2005 - Drug Information Page - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Palladone (hydromorphone hydrochloride): Audience: Pain Specialists and other healthcare professionals
[Posted 07/14/2005] FDA issued a public health advisory to notify health care professionals and consumers that the sponsor of Palladone, Purdue Pharma, has agreed to suspend sales and marketing of Palladone (hydromorphone hydrochloride, extended release capsules), a potent narcotic painkiller, because of the potential for severe side effects if Palladone is taken with alcohol. Drinking alcohol while taking Palladone may cause rapid release of hydromorphone, leading to high drug levels in the body, with potentially fatal effects. High drug levels of hydromorphone may depress or stop breathing, cause coma, and even cause death.

[July 13, 2005 - Public Health Advisory - FDA]
[July 13, 2005 - News Release - FDA]
[July 13, 2005 - Healthcare Professional Sheet [PDF] [HTML] - FDA]
[July 13, 2005 - Drug Information Page - FDA]
[July 13, 2005 - Questions and Answers - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Duragesic (fentanyl transdermal system): Audience: Pain Specialists, Oncologists and other healthcare professionals
[Posted 07/08/2005] Janssen and FDA notified healthcare professionals of changes to the BOXED WARNING/WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Duragesic. These changes include important safety information in the following areas of the labeling: Use Only in Opioid-Tolerant Patients, Misuse, Abuse and Diversion, Hypoventilation (Respiratory Depression), Interactions with CYP3A4 Inhibitors, Damaged or Cut Patches, Accidental Exposure to Fentanyl, Chronic Pulmonary Disease, Head Injuries and Intracranial Pressure, Interactions with Other CNS Depressants, and Interactions with Alcohol and Drugs of Abuse.

[June 2005 - Letter - Janssen]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Cialis (Tadalafil) Levitra (Vardenafil hydrochloride) Viagra (Sildenafil citrate): Audience: Urologists, Ophthalmologists and other healthcare professionals
[Posted 07/08/2005] FDA notified healthcare professionals of updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again. At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems. The new labeling information is available along with additional information for healthcare providers and consumers at:
Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)
Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)
Viagra (http://www.fda.gov/cder/consumerinfo/viagra/viagra.htm)

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Liqiang 4 Dietary Supplement Capsules: Audience: Consumers and Healthcare professionals
[Posted 07/05/2005] FDA notified consumers and healthcare professionals about the risks of taking Liqiang 4 Dietary Supplement Capsules because they contain glyburide – a drug that could have serious, life-threatening consequences in some people. The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge CA. Glyburide is a drug used to lower blood sugar, and is safe and effective when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities.

[July 01, 2005 - Talk Paper - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications: Audience: Neuropsychiatric healthcare professionals and consumers

[UPDATE 07/08/2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications.

[Posted 07/01/2005] In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has issued a Public Health Advisory to update patients and healthcare providers with the latest information on this subject. Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.

[July 08, 2005 - Healthcare Professional and Patient Information Sheets - FDA]
[July 01, 2005 - Talk Paper - FDA]
[June 30, 2005 - Public Health Advisory - FDA]
[June 30, 2005 - Drug Information Page - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Boston Scientific Hemashield VANTAGE Vascular Grafts: Audience: Vascular surgery healthcare professionals and surgical department managers
[UPDATE 09/09/2005] This recall was classified as a Class I recall

[Posted 06/28/2005] Boston Scientific and FDA notified healthcare professionals of a recall of all Hemashield VANTAGE vascular grafts manufactured in the last two years due to the potential for the device, used in peripheral procedures, to fray or tear during suturing and lead to post-operative complications. Boston Scientific is aware of three reported post-operative failures which occurred between three and seven days post-procedure. In all of these cases, the patients were successfully treated by re-suturing the graft or replacing it. Absent symptoms of graft failure, Boston Scientific is recommending that physicians continue routine post-operative clinical evaluation. The signs and symptoms that a graft might be starting to fail include: pain, swelling, bruising, bleeding through incision, rapid pulse or low blood pressure. If a patient experiences any of these symptoms, he or she should contact their physician immediately.

[September 09, 2005 - Recall Notice - FDA]
[June 27, 2005 - Press Release - Boston Scientific]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators: Audience: Cardiologists and other healthcare professionals
[UPDATE 07/29/2005] Guidant notified healthcare professionals in a letter issued July 22 that one of the safety recommendations made to physicians on June 17 regarding its VENTAK PRIZM, VITALITY, and CONTAK RENEWAL AVT implantable cardioverter defibrillators (ICDs) may significantly increase the risk to patients. Physicians are advised to schedule follow-up visits as soon as possible for patients with devices reprogrammed as per original instructions and for all patients with Atrial Episode Data Storage programmed to less than 20%.

[UPDATE 07/01/2005] FDA updated consumers with additional information on the relative health risks of the 11 devices affected by this recall.

[06/21/2005] FDA and Guidant Corporation notified health care providers and patients of the recall of certain implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices, surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm), can develop an internal short circuit without warning, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event. There have been two deaths reported to FDA suspected to be associated with this malfunction. The devices affected by this notification are: PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002; CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004; CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

[UPDATE July 22, 2005 - Dear Healthcare Professional Letter - Guidant]
[UPDATE July 01, 2005 - Press Release - FDA]
[UPDATE June 24, 2005 - Press Release - Guidant]
[UPDATE June 24, 2005 - FDA Statement - FDA]
[June 17, 2005 - Press Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Iressa (gefitinib): Audience: Oncology healthcare professionals
AstraZeneca and FDA notified healthcare professionals of new approved labeling for Iressa that states the medicine should be used only in cancer patients who have already taken the medicine and whose doctor believes it is helping them. New patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer.

[June 17, 2005 - Public Health Advisory - FDA]
[June 17, 2005 - Drug Information Page - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Quality Care Products L.L.C./Able Laboratories Inc. Drugs: Audience: Pharmacists
Quality Care Products, LLC, a federally licensed drug re-packager, and FDA notified healthcare professionals of a nationwide recall of any and all numbers repackaged from drugs that were manufactured by Able Laboratories Inc. This recall is due to Able Laboratories voluntary recall of all of their drug products because of the FDA's serious concerns that they were not produced according to quality assurance standards.

[June 15, 2005 - Press Release - Quality Care Products L.L.C.]

Related MedWatch Alerts:

June 01, 2005 - Able Laboratories Products - Recall of all Manufactured Drugs

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Accusure Insulin Syringes 1cc, 28 Gauge 1/2 Inch: Audience: Pharmacists. hospital risk managers, and consumers
Qualitest Pharmaceuticals and FDA notified healthcare professionals and consumers of a voluntary nationwide recall of AccuSure Insulin Syringes 1cc, 28 Gauge 1/2 Inch, distributed between October 2004 and June 2005. There may be 1cc syringes which are mislabeled as 1/2 cc syringes on the plastic inner wrap holding 10 Individual syringes, which could potentially result in confusion by the patient or caregiver, resulting in an incorrect dose or amount being administered.

[June 14, 2005 - Recall Notice - Qualitest Pharmaceuticals]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Audience: Healthcare professionals and consumers
FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.

[June 15, 2005 - Drug Information Page - FDA]
[June 15, 2005 - Medication Guide - FDA-Approved] PDF Format

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Sustiva (efavirenz) Capsules and Tablets: Audience: Infectious disease and other healthcare professionals, consumers
Bristol-Myers Squibb and FDA notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Pregnancy and Information for Patients, and PATIENT INFORMATION sections of the prescribing information for Sustiva (efavirenz), indicated in the treatment of HIV-1 infection. The revisions are a result of four retrospective reports of neural tube defects in infants born to women with first trimester exposure to Sustiva, including three cases of meningomyelocele and one Dandy Walker Syndrome. As Sustiva may cause fetal harm when administered during the first trimester to a pregnant woman, pregnancy should be avoided in women receiving Sustiva. An antiretroviral pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to Sustiva.
[March, 2005 - Dear Healthcare Professional Letter - Bristol-Myers Squibb]
[February, 2005 - Label - Bristol-Myers Squibb ]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Children's Tylenol Meltaways - 80 Mg Children's Tylenol Softchews - 80 Mg Jr. Tylenol Meltaways - 160 Mg: Audience: Consumers and healthcare professionals
McNeil Specialty Pharmaceuticals and FDA notified consumers and healthcare professionals about a nationwide recall of all lots and all flavors of Children's TYLENOL Meltaways 80 mg, Children's TYLENOL SoftChews 80mg, and Junior TYLENOL Meltaways 160mg. The recall addresses issues regarding the design of the blister package, information on the package, and bottle cartons for the products that may be confusing and lead to improper dosing, including overdosing.
[June 03, 2005 - Press Release - McNeil]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Able Laboratories Products - Recall of all Manufactured Drugs: Audience: All Healthcare professionals and consumers
The Food and Drug Administration notified consumers and healthcare professionals of a nationwide recall of all manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) from Able Laboratories of Cranbury, NJ, because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production. FDA recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their health care provider. FDA has provided a list with the names of the recalled drugs and their imprint codes, marks (usually letters and numbers) found on the surfaces of drugs.

[May 27, 2005 - Press Release - FDA]

UPDATE - see related safety alert on Quality Care Products, LLC

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Novantrone (mitoxantrone for injection concentrate): Audience: Neurologists, oncologists, cardiologists, and consumers
Serono and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Novantrone [mitoxantrone], indicated for treatment of multiple sclerosis (MS). The Dear Healthcare Professional letter provides additional information concerning the risks of cardiotoxicity associated with Novantrone and also provides supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with Novantrone.

[April, 2005 - Dear Healthcare Professional Letter - Serono]
[March, 2005 - Label - Serono]
[March, 2005 - Patient Information - Serono]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Dextromethorphan: Audience: Healthcare professionals and consumers
FDA issued a Talk Paper to notify the public about the abuse of dextromethorphan (DXM), an ingredient found in many over-the-counter (OTC) cough and cold remedies. The agency is working with other health and law enforcement authorities to address this serious issue and warn the public of potential harm, after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules.

[May 20, 2005 - Talk Paper - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

TMM brand Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer: Audience: Consumers
The Master's Miracle (TMM) company of Minneapolis, Minn., and FDA alerted the public against applying the company's TMM brand Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer to the eyes because these products may be contaminated with Pseudomonas aeruginosa, Pseudomonas flourescens/putida and Enterobacter cloacae -- bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. The products are labeled as a Dietary Supplement and distributed nationwide in 8 oz., 20 oz. and one-gallon size containers.

[May 18, 2005 - Press Release - TMM]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Natrecor (nesiritide)

Audience: Cardiologists/cardiovascular healthcare professionals
Scios and FDA notified healthcare professionals of revisions to the ADVERSE REACTIONS/Effect on Mortality section of the prescribing information for Natrecor [nesiritide], indicated for patients with acutely decompensated congestive heart failure. The Dear Healthcare Professional letter also provided information from Scios on several published reports that raise the question of whether the product may have adverse effects on survival and kidney function compared to control agents (generally nitroglycerin and diuretics).

[May 6, 2005 - Dear Healthcare Professional Letter - Scios]
[April, 2005 - Natrecor Label - Scios]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Albumin Administration in Critically Ill Patients: Audience: Critical care healthcare professionals
The FDA notified healthcare professionals of an update and revision to a 1998 notice with advice regarding the safety of albumin administration in critically ill patients. This action has been taken following FDA’s review of recent studies on the safety of albumin, and is consistent with recommendations made on March 17, 2005 by members of the Blood Products Advisory Committee (BPAC).

[May 16, 2005 - Notice - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Zometa (zoledronic acid) Aredia (pamidronate disodium)

Audience: Dental and oncologic healthcare professionals
Novartis and FDA notified dental healthcare professionals of revisions to the prescribing information to describe the occurence of osteonecrosis of the jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia (pamidronate disodium) and Zometa (zoledronic acid). The prescribing information recommends that cancer patients receive a dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa), and avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition.

Aredia is used in the treatment of hypercalcemia of malignancy, Paget’s disease, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. Zometa is used in the treatment of hypercalcemia of malignancy, the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

[May 05, 2005 - Dear Dentist Letter - Novartis]
[November 2004 - Zometa Label - Novartis]
[August 2004 - Aredia Label - Novartis]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

BioMerieux Simplastin HTF Tissue Reagent: Audience: Laboratory supervisory personnel and healthcare professionals
BioMerieux and FDA notified healthcare professionals of a class 1 recall of MDA Simplastin HTF (human thromboplastin factor) tissue reagent, a tissue thromboplastin reagent used in determination of the prothrombin time (PT) in human plasma. The prothrombin time (PT) laboratory test is used to control the use of oral anticoagulant therapy, (i.e. Coumadin) in patients with bleeding disorders. Mislabeling problems with certain lots of this product could result in inaccurate test results, which in turn could lead to improper patient treatment – in some cases resulting in serious or life-threatening injury. Although BioMerieux initiated a recall of these products in March 2005, its notifications to purchasers incorrectly indicated that the problem was of no clinical significance. The company is now clearly informing its customers about the importance of this problem and the need to respond to it. Laboratories that have this reagent should not use it, but instead contact the company. Laboratories that have used this reagent should also contact any physicians or medical institutions whose patients may be affected by this problem.

[May 16, 2005 - Recall Notice - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

MRL Inc. AED20 Automatic External Defibrillators: Audience: Emergency healthcare professionals and Cardiologists
MRL Inc. and FDA notified healthcare professionals of a voluntary worldwide recall of 597 AED20 Automatic External Defibrillators manufactured between February and July of 2004. The AED20 may display a “Defib Comm” error message during use resulting in a failure of the device to analyze the patient’s ECG and deliver the appropriate therapy which prevents the defibrillator from resuscitating a patient. The company has received 12 related complaints with this specific group of AED20’s, including one instance which may have prevented patient resuscitation.

[May 13, 2005 - Recall Notice - FDA]
[May 10, 2005 - Press Release - MRL Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

LifeScan, Inc. OneTouch Ultra, InDuo and OneTouch FastTake Blood Glucose Meters: Audience: Healthcare professionals and consumers
LifeScan, Inc, initiated a worldwide notification to all users of its OneTouch Ultra, InDuo and OneTouch FastTake Meters. LifeScan found that it was possible for consumers, in the course of setting their meter's date and time, to accidentally change the unit of measure and thereby misinterpret their blood glucose results. The notification program includes letters to registered users and health care professionals, and also special instructions inserted in each package of test strips. The products are distributed worldwide primarily through retail pharmacy and mail order channels.

[May 17, 2005 - Recall Notice - FDA]
[May 10, 2005 - Press Release - LifeScan, Inc]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Counterfeit Drugs Purchased in Mexico: Audience: Healthcare professionals and consumers
The FDA warned the public about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" to U.S. consumers at pharmacies in Mexican border towns. The "generic Evista" was analyzed by FDA in coordination with the National Association of Boards of Pharmacy and was found to contain no active ingredient. The counterfeit Lipitor and counterfeit Viagra were analyzed by Pfizer, Inc. and were also found to contain no active ingredient. Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately.

[May 10, 2005 - Talk Paper - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

MRI-Caused Injuries in Patients with Implanted Neurological Stimulators: Audience: Radiology personnel, neurosurgeons, and hospital risk managers
FDA notified healthcare professionals that serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures. The FDA received several reports of serious injury, including coma and permanent neurological impairment. The mechanism for these adverse events is likely to involve heating of the electrodes at the end of the leadwires, resulting in injury to the surrounding tissue. The public health notification also offered recommendations for preventive actions.

[May 10, 2005 - Public Health Notification - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Laerdal CM 100-Heartstart Adapter Cable: Audience: Emergency healthcare professionals and Cardiologists
Laerdal Medical Corporation and FDA notified healthcare professionals of a voluntary recall of all lots of CM 100-Heartstart Adapter Cable, Cat. No. 920650 (Adapter Cable). Wires within the defibrillator adapter cables are susceptible to breakage that prevented delivery of defibrillation shocks. The test method described in the defibrillator instructions for use will not detect internal breaks in the adapter cables. Use of these Adapter Cables should be discontinued.

[May 13, 2005 - Recall Notice - FDA]
[April 28, 2005 - Press Release - Laerdal]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Famotidine Injection, 20 mg/2 mL: Audience: Pharmacists and other healthcare professionals
Bedford Laboratories and FDA notified healthcare professionals of the voluntary recall of one lot of Famotidine Injection, 20 mg/2 mL (NDC 55390-029-10), Lot# 609336, exp. 04/06, due to a lack of sterility assurance. This prescription product was distributed in August 2004 throughout the United States to wholesalers and distributors, who further distributed the product to hospitals.
[April 29, 2005 - Press Release - Bedford Laboratories, Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Kingswood Laboratories Moi-Stir Oral Swabsticks: Audience: Physicians, Dentists, Hospital and Long Term Care facility administrators
Kingswood Laboratories, Inc and FDA notified healthcare professionals of a nationwide recall of Moi-Stir Oral swabsticks due to the finding that certain lots contain molds including Aspergillus and Penicillium which could result in respiratory infections. The swabsticks contain a saliva supplement intended to relieve dry mouth, physically clean the oral cavity, thin phlegm, and lower dental caries rates. The product was distributed to hospitals, hospital wholesalers, pharmacies, nursing homes, physician and dentist offices, consumers, some government medical facilities, and as free samples to a small number of individuals. Doctors and dentists should consider screening patients who are at risk for infections, especially those with weakened immune systems (low white blood cell counts) who have used the Moi-Stir Swabstick.

[April 22, 2005 - Press Release - Kingswood Laboratories, Inc]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Xigris [drotrecogin alfa (activated)]: Audience: Pediatricians, intensivists and infectious disease healthcare professionals
Eli Lilly and FDA notified healthcare professionals of the stopping of enrollment in a randomized, double-blind, placebo-controlled trial of Xigris in pediatric patients with severe sepsis. Xigris is not indicated for use in pediatric severe sepsis. A planned interim analysis showed that Xigris was highly unlikely to show an improvement over placebo in the primary endpoint of "Composite Time to Complete Organ Failure Resolution" over 14 days.

A numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group was also noted. Over the infusion period the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less.

[April 21, 2005 - Letter - Eli Lilly] PDF Format
[December 2004 - Label - Eli Lilly]

Previous 2005 MedWatch alert

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Neurontin (gabapentin): Audience: Neuropsychiatric healthcare professionals, pharmacists and consumers
Pfizer Inc. and FDA notified healthcare professionals of the voluntary recall of one lot (40,000 bottles) of 100 mg capsules of its epilepsy medication, Neurontin, after a manufacturing mechanical failure resulted in some bottles containing empty or partially filled capsules. Patients taking Neurontin to control epilepsy could experience seizures from a missed dose of the product. 100 mg strength capsules from lot #15224V -- distributed in October and November, 2004 -- are included in the recall. The production lot was distributed only in the United States. No other Neurontin lots were affected.

[April 22, 2005 - Press Release - Pfizer]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Betaseron (interferon beta-1b): Audience: Neuropsychiatric healthcare professionals
Berlex, Inc. reminded healthcare professionals of the prescribing information for Betaseron (interferon beta-1b) as it pertains to hepatic toxicity. Betaseron is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. There have been reports during post-marketing safety surveillance of serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant. Liver function testing is recommended at regular intervals (one, three, and six months) following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms.

[April 15, 2005 - Letter - Berlex]
[October 2003 - Label - Berlex]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Trileptal (oxcarbazepine) Tablets and Oral Solution: Audience: Neuropsychiatric healthcare professionals and consumers
Novartis Pharmaceuticals and FDA notified healthcare professionals about revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for TRILEPTAL (oxcarbazepine) tablets and oral suspension, indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 years with epilepsy. The updated WARNINGS section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use.

[April 18, 2005 - Dear Healthcare Professional Letter - Novartis]
[March 2005 - Revised Label, Highlighted - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

MicroScan Rapid Pos Inoculum Broth: Audience: Clinical microbiological laboratory personnel
Dade Behring and FDA notified healthcare professionals of a class 1 recall of MicroScan Rapid Pos Inoculum Broth, Lot numbers 050905A-1, 051005A-1, 051605A-1, 051705A-1, 052305B-1, and 052805B-1 used to inoculate MicroScan® Rapid Fluorogenic Gram Positive MIC/BP panels, which are intended for the determination of antimicrobial susceptibility of gram-positive organisms. The recall was initiated to prevent health risk to patients due to potential false antibiotic susceptibility results. The possibility of inaccurate susceptibility results for a pathogen could lead a physician to prescribe incorrect or suboptimal therapy.
[April 14, 2005 - Recall Notice - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Atypical Antipsychotic Drugs: Audience: Neuropsychiatric healthcare professionals, patients and caregivers
The Food and Drug Administration has issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved, “off-label” use of certain antipsychotic drugs approved for the treatment of schizophrenia and mania. FDA has determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality. Clinical studies of these drugs in this population have shown a higher death rate associated with their use compared to patients receiving a placebo.

[April 11, 2005 - Public Health Advisory - FDA]
[April 11, 2005 - Drug Information Page - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Audience: Healthcare professionals and consumers
After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on:

* The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

* Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

* Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Patients currently taking Bextra should contact their physicians to consider alternative treatments. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.

[April 07, 2005 - Public Health Advisory - FDA]
[April 07, 2005 - Drug Information Page - FDA]
[April 07, 2005 - Questions and Answers - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Reminyl (galantamine hydrobromide): Audience: Neuropsychiatric healthcare professionals
Ortho-McNeil Neurologics modified the PRECAUTIONS section of the Prescribing Information for Reminyl, approved only for the treatment of mild to moderate Alzheimer’s Disease. The changes provide new safety information regarding the results of two randomized, placebo-controlled trials of 2 years duration in subjects with mild cognitive impairment (MCI). A total of 13 subjects on REMINYL (n=1026) and 1 subject on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population. About half of the REMINYL deaths appeared to result from various vascular causes (myocardial infarction, stroke), and sudden death.

[March 31, 2005 - Letter - Ortho-McNeil Neurologics]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



B-Sure brand One-Step Home Pregnancy Test: Audience: Consumers and reproductive healthcare professionals
Harmony Brands, Oak Park, Michigan, a national distributor of health, cosmetic and other consumer products, is voluntarily recalling its B-Sure brand One-Step Home Pregnancy Test because its safety and efficacy can no longer be assured. Consumers who have the product in their possession should not use it and should return the product to the point of purchase for a refund. Women who have used the test may wish to contact their health care provider to verify the test results. There have been no reports of failures of the product, and there have been no reports of injury or illness associated with their use. The test was sold throughout the United States in a variety of retail outlets, including Dollar Stores and convenience stores.

[March 25, 2005 - Press Release - Harmony Brands]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Zometa (zoledronic acid): Audience: Oncologists, Endocrinologists, Pharmacists and other healthcare professionals
Novartis and FDA notified healthcare professionals of revisions to the DOSAGE AND ADMINISTRATION and WARNINGS sections of the prescribing information to reflect new safety information on management of patients with advanced cancer and renal impairment, whose baseline creatinine clearance is 60 ml/min or lower. The recommended Zometa doses for patients with reduced renal function (mild and moderate renal impairment) are provided in a table. It is recommended that, during treatment, serum creatinine be measured before each dose and treatment should be withheld for renal deterioration.
[December 20, 2004 - Dear Healthcare Professional Letter - Novartis]
[November 2004 - Revised Label - Novartis]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Trecator (ethionamide tablets, USP) Tablets: Audience: Infectious disease specialists and other healthcare providers
Wyeth Pharmaceuticals announced that Trecator-SC (ethionamide tablets, USP) Sugar-Coated Tablets have been reformulated to film-coated tablets and renamed Trecator. The new film-coated tablet is more rapidly absorbed, resulting in higher peak concentrations (Cmax) of ethionamide, which may potentially lead to patient intolerance when introduced at the same initial dose as the old sugar-coated tablet. As a result, patients should be monitored and have their dosages re-titrated when switching from the sugar-coated tablet to the film-coated tablet.
[March 10, 2004 - Dear Healthcare Professional Letter - Wyeth]
[March 10, 2004 - Dear Pharmacist Letter - Wyeth]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Vail 500, 1000, and 2000 Enclosed Bed Systems: Audience: Hospital and Extended Care Facility Administrators, Risk Managers and consumers
[03/23/2005] FDA and the Department of Justice initiated seizures of all finished Vail 500, 1000, and 2000 Enclosed Bed Systems made by Vail Products, Inc., in a response to ongoing concerns about manufacturing quality and labeling. Use of these systems poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death. FDA is aware of approximately 30 entrapments resulting from use of the Vail Enclosed Bed Systems, of which at least 7 resulted in death. FDA advises consumers to stop using Vail 500, 1000 and 2000 Enclosed Bed Systems until they receive additional instructions from Vail Products.

[UPDATE 06/24/2005] - Vail Products is permanently ceasing the manufacture, sale and distribution of all Vail enclosed bed systems, and will no longer be available to provide accessories, replacement parts, or retrofit kits. On June 23 and 24, 2005, revised instruction manuals and warning labels were mailed to customers with Vail 500, Vail 1000 or Vail 2000 enclosed bed systems. The revised manuals include new warnings, precautions, and instructions for use. FDA is advising 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 can consult with their physicians about other options.
[March 22, 2005 - Talk Paper - FDA]
[March 25, 2005; UPDATED June 24/2005 - Preliminary Public Health Notification - FDA]
[June 30, 2005 - Recall Notice - FDA]
[June 30, 2005 - Press Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



HeartSine Technologies, Inc. Samaritan Automatic External Defibrillators (AED): Audience: Emergency healthcare professionals and Cardiologists
FDA and HeartSine Technologies, Inc. notified healthcare professionals of a worldwide recall of HeartSine samaritan AED models SAM-001, SAM-002, and SAM-003 with certain serial numbers within the range of 1270 - 2324. These devices may in some cases shut down before delivering a shock, which could result in a delay in treatment or death. This recall was initiated after receipt of several user complaints of shut-down during an attempted charge. HeartSine Technologies, Inc. believes that some of the affected devices could exhibit longer than usual charging rates, causing an alarm and shutdown of the device. Distributors and customers should contact the manufacturer to determine if their product(s) are affected, and arrange to obtain a field upgrade kit as soon as possible.
[March 22, 2005 - Recall Notice - FDA]
[March 18, 2005 - Press Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution: Audience: Pharmacists, Operating Room, and Nursing Personnel
[March 21, 2005] FDA and PharMEDium Services of Houston notified healthcare professionals of the withdrawal of one lot of PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, which may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems. This product is frequently administered intravenously to patients undergoing cardiac surgery and was apparently distributed to several hospitals around the country. To date it has been associated with at least 5 recent cases of Serratia marcescens infection in a hospital in New Jersey. FDA, the U.S. Centers for Disease Control and Prevention, and other public health authorities are investigating this problem to determine if other lots of this product may be affected.
[UPDATE April 8, 2005] - PharMEDium Services is recalling all strengths of 50 ml admixtures of Magnesium Sulfate in 5% Dextrose solution because of a potential lack of sterility assurance for these products. In addition, the company is voluntarily ceasing production and distribution of this product until it can determine and correct the source of this problem.

[April 8, 2005 - Press Release - PharMEDium Services]
[March 18, 2005 - Statement - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Xigris [drotrecogin alfa (activated)]: Audience: Infectious Disease healthcare professionals, Intensivists, and other healthcare professionals
Eli Lilly and FDA notified healthcare professionals about revisions to the WARNINGS section of labeling for Xigris [drotrecogin alfa (activated)], a biological therapeutic product indicated for the treatment of adult patients with severe sepsis who are at high risk of death. This warning is based upon analyses of two clinical trial databases. Among patients with single organ dysfunction and recent surgery, all-cause mortality was numerically higher in the Xigris group compared to the placebo group. Patients with single organ dysfunction and recent surgery may not be at high risk of death and therefore may not be among the indicated population. Xigris should be used in these patients only after careful consideration of the risks and benefits.

[March 2005 - Letter - Eli Lilly] PDF Format
[December 2004 - Revised Label - Eli Lilly]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Avonex (interferon beta-1a): Audience: Neurologists and other healthcare professionals
FDA and Biogen notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Drug Interactions and ADVERSE REACTIONS/Post-Marketing Experience sections and Medication Guide. Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking Avonex. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of Avonex used in combination with known hepatotoxic drugs or other products (e.g. alcohol) should be considered prior to Avonex administration, or when adding new agents to the regimen of patients already on Avonex.

[March 2005 - Letter - Biogen]
[February 2005 - Revised Label - Biogen]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Elidel (pimecrolimus) Protopic (tacrolimus): Audience: Dermatological and other healthcare professionals
The FDA issued a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel (pimecrolimus) and Protopic (tacrolimus), products that are applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies of ten years or longer to determine if use of Elidel or Protopic is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel and Protopic should be used only as labeled, for patients who have failed treatment with other therapies.

[March 10, 2005 - Public Health Advisory - FDA]
[March 10, 2005 - Talk Paper - FDA]
[March 10, 2005 - Elidel Drug Information Page - FDA]
[March 10, 2005 - Protopic Drug Information Page - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Paxil CR (paroxetine hydrochloride) Avandamet (rosiglitazone maleate + metformin hydrochloride): Audience: Healthcare providers and consumers
FDA and the Department of Justice have seized the remaining stocks of Paxil CR and Avandamet tablets manufactured by GlaxoSmithKline, Inc. Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and Type II Diabetes (Avandamet), failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity. FDA is not aware of any harm to consumers by the products subject to this seizure and it does not believe that these products pose a significant health hazard to consumers. Consequently, FDA urges patients who use these two drugs to continue taking their tablets and to talk with their health care provider about possible alternative products for use until the manufacturing problems have been corrected. FDA has determined that there are other products to treat the diseases for which these two products are used. (See questions and answers).

[March 4, 2005 - FDA News - FDA]
[March 4, 2005 - Questions and Answers - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Crestor (rosuvastatin calicum)

Audience: Physicians, pharmacists, and other healthcare professionals
FDA issued a public health advisory describing revisions to the WARNINGS, DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY, and PRECAUTIONS sections of the labeling. The revisions include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. At this time, the FDA is also making statements about the muscle and kidney safety of Crestor based on extensive review of available information.

[March 2, 2005 - Public Health Advisory - FDA]
[March 2, 2005 - Drug Information Page - FDA]
[January 2005 - Revised Label - Astra-Zeneca]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Medtronic LIFEPAK 500 Automated External Defibrillators: Audience: Emergency healthcare professionals and Cardiologists
[03/02/2005] Medtronic, Inc. and FDA advised healthcare professionals of a Class 1 recall of the LIFEPAK 500 automated external defibrillators (AEDs). The AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed. This action affects 1,924 first-generation LIFEPAK 500 AEDs that were manufactured in 1997, which represents approximately 1 percent of LIFEPAK 500 AEDs currently in use worldwide. This action does not affect any other LIFEPAK 500 AEDs currently produced, or any other LIFEPAK product. The company will update or upgrade customer devices at no charge by March 31, 2005. The affected AEDs may remain in service and customers are currently being contacted with recommendations for use and replacement schedules.

UPDATE April 25, 2005 - An additional 396 monophasic LIFEPAK 500 AEDs were included in a voluntary recall originally announced on February 25, 2005. See link below.

[April 22, 2005 - Press Release - Medtronic, Inc.]
[February 25, 2005 - Press Release - Medtronic, Inc.]
[March 1, 2005 - Recall Notice - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Tysabri (natalizumab)

Audience: Neurological and other healthcare professionals
[02/28/2005] FDA issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use. FDA received reports of one confirmed, fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis. Although the relationship between Tysabri and PML is not known at this time, because of the rare, serious and often fatal nature of PML, FDA announced the following, effective immediately:

- Biogen Idec is voluntarily suspending marketing of Tysabri.
- Biogen Idec is suspending dosing of Tysabri in clinical trials and is notifying patients and investigators of the possible association between Tysabri and PML.

Patients being treated with Tysabri should contact their physician to discuss appropriate alternative treatments. At this time, there are no specific diagnostic or therapeutic interventions recommended for patients who have been taking Tysabri, other than to discontinue its use. Physicians should evaluate all patients who have received Tysabri and who have signs or symptoms suggestive of PML. Any suspect cases of PML should be reported immediately to Biogen Idec or to the FDA MedWatch program.

UPDATE April 04, 2005 - Dear Healthcare Professional letter link added below.
UPDATE March 30, 2005 - Dear Healthcare Professional letter link added below.

[April 4, 2005 - Dear Healthcare Professional Letter - Biogen]
[February 28, 2005 - Public Health Advisory - FDA]
[March 23, 2005 - Dear Healthcare Professional Letter - Biogen]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Gabitril (tiagabine): Audience: Neuropsychiatric and other healthcare professionals
FDA and Cephalon, Inc. notified healthcare professionals and the public that a Bolded Warning has been added to the labeling for Gabitril (tiagabine) to warn prescribers of the risk of seizures in patients without epilepsy being treated with Gabitril. FDA has received reports of the occurrence of seizures in more than 30 patients prescribed Gabitril for conditions other than epilepsy. Most of these uses were in patients with psychiatric illnesses. Such off label prescribing is a common practice among physicians. Because of the risk of seizures, however, in addition to adding the Bolded Warning to product labeling, the sponsor has agreed to undertake an educational campaign, targeted to healthcare professionals and patients, in which such off-label use will be discouraged.

[February 14, 2005 - Letter - Cephalon, Inc.]
[February 18, 2005 - Public Health Advisory - FDA]
[February 18, 2005 - Drug Information Page - FDA]
[February 2005 - Revised Label - Cephalon, Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch



Phenergan (promethazine hydrochloride): Audience: Pediatricians and other healthcare professionals
FDA and Wyeth notified healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Phenergan. Phenergan is contraindicated for use in pediatric patients less than two years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression including fatalities, have been reported with use of Phenergan in pediatric patients less than two years of age. Caution should also be exercised when administering Phenergan to pediatric patients two years of age and older.

[January 21, 2005 Letter - Wyeth]
[December, 2004 Revised Label - Wyeth]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Similac Advance with Iron powdered infant formula: Audience: Pediatricians, other healthcare providers, and consumers
FDA and the Ross Products Division of Abbott Laboratories announced a recall of one lot of Similac Advance with Iron powdered infant formula in 12.9-ounce cans, Lot Number 20307RB due to the presence of black plastic particles reported in a small number of cans. The particles are the result of an isolated manufacturing event that has already been corrected. No serious health or safety reports have been received that are attributed to this situation. This formula was distributed between September 15, 2004 and October 18, 2004 primarily in the Eastern half of the United States and in Iowa, Kansas, and Missouri.

[February 2, 2005 - Press Release - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Medtronic Implantable Defibrillator models: Audience: Cardiologists and other healthcare professionals
Medtronic, Inc. and FDA advised physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that batteries have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths. Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect™ CRT-D devices.

[February 11, 2005 - Press Release - Medtronic, Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Adderall XR (amphetamine): Audience: Neuropsychiatric and other healthcare professionals
FDA issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients. FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6-12 years old with ADHD, and Adderall, the immediate release formulation of the drug, is approved for pediatric patients with ADHD.

[February 10, 2005 - Drug Information Page - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Agrylin (anagrelide hydrochloride): Audience: Hematology/Oncology and other healthcare professionals
Shire and FDA notified healthcare professionals about changes to the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Agrylin (anagrelide hydrochloride), a medication approved for the treatment of thrombocythemia secondary to myeloproliferative disorders to reduce platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombohemorrhagic events. Pharmacokinetic studies have revealed an 8-fold increase in total exposure (AUC) to anagrelide hydrochloride in patients with moderate hepatic impairment. Use of anagrelide hydrochloride has not been studied in patients with severe hepatic impairment. Labeling changes include the contraindication to the use of Agrylin in patients with severe hepatic impairment. The WARNINGS section describes the need for dosage reduction in patients with moderate hepatic impairment and the necessity of monitoring these patients carefully for cardiovascular effects.
[January 2005 - Letter - Shire Development Inc.]
[December 2004 - Label - Shire Development Inc.]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Invirase (saquinavir mesylate capsules and tablets) Fortovase (saquinavir soft gelatin capsules): Audience: Infectious disease and other healthcare professionals
Roche and FDA notified healthcare professionals about an Important drug interaction warning. Drug-induced hepatitis with marked transaminase elevations has been observed in healthy volunteers receiving rifampin 600 mg once daily in combination with ritonavir 100 mg/saquinavir 1000 mg twice daily (ritonavir boosted saquinavir). Roche now advises prescribers that Rifampin should not be administered to patients also receiving saquinavir/ritonavir (ritonavir boosted
saquinavir) as part of combination antiretroviral therapy (ART) for HIV infection.
[February 2005 - Letter - Roche]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


ZyPREXA (olanzapine): Audience: Neuropsychiatric healthcare professionals and pharmacists
Eli Lilly and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between the atypical antipsychotic ZyPREXA (olanzapine), indicated for the short-term and maintenance treatment of schizophrenia and for the short-term treatment of acute mixed or manic episodes associated with Bipolar I Disorder, and the antihistamine ZYRTEC (cetirizine HCI) marketed by Pfizer, indicated for the treatment of allergic rhinitis or chronic urticaria. These reports include instances where Zyprexa was incorrectly dispensed for Zyrtec and vice versa, leading to unnecessary adverse events or potential relapse in patients suffering from schizophrenia or bipolar disorder.
[January 26, 2005 - Letter - Eli Lilly]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Home-Use Diagnostic Kits Marketed by Globus Media: Audience: Consumers and healthcare professionals
The FDA warned consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada. No home-use test kits intended for diagnosing HIV, syphilis and dengue fever are approved for sale in the U.S. The use of these products could result in false results (though there is no confirmed evidence of false positives) that could lead to significant adverse health consequences. The tests were sold through web sites and distributed throughout the U.S., usually by overnight delivery services. FDA has not approved or evaluated the performance of any of Globus Media's products. As a result, consumers cannot know with any degree of certainty that test results are correct. See the FDA Talk Paper for a complete list of all test kits affected by this notice.
[February 7, 2005 - Talk Paper - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


IV Flush Brand of Preloaded Syringes Containing Heparin or Sodium Chloride: Audience: Hospital risk managers, pharmacists, nursing administrators, and other healthcare professionals
FDA is issuing a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by the IV Flush, LLC and distributed by Pinnacle Medical Supply, of Rowlett, Texas, because they lacked proper FDA clearance for marketing. FDA and the company have also been informed of Pseudomonas fluorescens (P. fluorescens) infections in patients possibly caused by the heparin flushes.
[UPDATE February 4, 2005 - Press Release - FDA]
[January 31, 2005 - Press Release - FDA]
[February 25, 2005 - Recall Notice - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch


Becton Dickinson ProbeTec ET Urine Processsing Kit: Audience: Laboratory supervisory personnel and healthcare professionals
FDA and Becton Dickinson notified healthcare professionals of a Class 1 recall of the ProbeTec ET Urine Processing Kit, designed to aid in testing male and female urine specimens for Chlamydia and gonorrhea. This laboratory test may cause indeterminate and false negative clinical results which could lead to the patient not receiving treatment. Untreated infection could result in worsening infections, further disease transmission, pelvic inflammatory disease, infertility, ectopic pregnancy and other sequellae.

[January 31, 2005 - Recall Notice - FDA]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Viramune (nevirapine): Audience: Infectious Disease healthcare professionals
FDA issued a public health advisory to inform health care providers and patients about recent safety-related changes to the nevirapine (Viramune®) label and about appropriate use of HIV triple combination therapy containing nevirapine, a treatment option in the United States which is increasingly being used globally. The Indications and Usage section now recommends against starting nevirapine treatment in women with CD4+cell counts greater than 250 cells/mm3 unless benefits clearly outweigh risks. This recommendation is based on a higher observed risk of serious liver toxicity in patients with higher CD4 cell counts prior to initiation of therapy. In addition, the revised label now includes a Medication Guide to inform patients about risks associated with nevirapine when used for the treatment of HIV.

[January 19, 2005 - FDA Public Health Advisory - FDA]
[January 2005 - Revised Label - Boehringer Ingelheim]
[January 2005 - Medication Guide - Boehringer Ingelheim]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Methylin CT (Methylphenidate HCl Chewable Tablets): Audience: Pharmacists, Pediatricians, Neuropsychiatric healthcare professionals
[01/19/2005] FDA and Alliant Pharmaceuticals notified healthcare professionals and consumers of the voluntary recall of one lot of Methylphenidate HCl Chewable Tablets, 5 mg strength,indicated for Attention Deficit Hyperactivity Disorder and Narcolepsy. After testing and evaluation, Alliant found that lot number #AMT50402A [expiration date April 2006] might contain up to three times the active ingredient, and elected to recall the medication as it could pose serious health risk for some patients.
[UPDATE 02/10/2005] Recall expanded to include all lots of the product. The nationwide recall now includes all 2.5 mg, 5 mg and 10 mg dosage strengths because some tablets may contain too much or too little active ingredient.

[February 09, 2005 - Firm Press Release - Alliant Pharmaceuticals]
[January 14, 2005 - Firm Press Release - Alliant Pharmaceuticals]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Aranesp (darbepoetin alfa): Audience: Oncologists, hematologists and other healthcare professionals
FDA and Amgen notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Aranesp, indicated for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. This safety information alerts physicians to the adverse effects observed with other products in this class in association with off-label dosing strategies. Two recent investigational studies with other erythropoietic products permitted or required dosing to achieve hemoglobin levels of greater than 12 grams per deciliter. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events were reported in these studies. As indicated in the Aranesp prescribing information, the target hemoglobin level should not exceed 12 grams per deciliter in men or women.

[January 11, 2005 - Letter - Amgen]
[December 16, 2004 - Label - Amgen]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Cordarone (amiodarone HCl)

Audience: Cardiologists, pharmacists and other healthcare professionals
FDA and Wyeth notified pharmacists and physicians of a new Medication Guide for Cordarone (amiodarone hydrochloride tablets). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/labeling.htm. The Medication Guide and current Prescribing Information for Cordarone and its generic equivalents are also provided below.

[December 30, 2004 - Dear Healthcare Professional Letter - Wyeth] PDF Format

[December 30, 2004 - Dear Pharmacist Letter - Wyeth] PDF Format

[December, 2004 - Label - Wyeth]

[December, 2004 - Medication Guide - Wyeth]

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

Avastin (bevacizumab): Audience: Oncologists and other healthcare professionals
FDA and Genentech notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS, ADVERSE EVENTS, and DOSAGE AND ADMINISTRATION sections of the Avastin labeling. Avastin, used in combination with intravenous 5-fluorouracil–based chemotherapy, is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum. Arterial thromboembolic events, including cerebral infarction, transient ischemic attacks (TIAs), myocardial infarction (MI), and angina, occurred at a higher incidence in patients receiving Avastin in combination with chemotherapy as compared to those receiving chemotherapy alone. These events were fatal in some instances.
In randomized, active-controlled studies, the overall incidence of arterial thromboembolic events was increased with the use of Avastin in combination with chemotherapy (4.4% vs. 1.9%). The incidences of both cerebrovascular arterial events (1.9% vs. 0.5%) and cardiovascular arterial events (2.1% vs. 1.0%) were increased in patients receiving Avastin in combination with chemotherapy. In addition, there was a correlation between age (65 years and over) and the increase in risk of thromboembolic events. The risk of these events should be viewed in the context of Avastin's ability to improve overall survival in patients with metastatic colorectal cancer.

[January 5, 2005 Letter - Genentech]
[January 5, 2005 Label - Genentech]

Previous MedWatch Safety Alert

August, 2004

Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch

2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

How to Find a Safety Summary

Biologics (CBER):

Special Nutritional Products and Cosmetics:

Drugs and Therapeutic Biological Products (CDER):

Medical Devices: