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Arsenic trioxide (Posted: 03/19/2001)
Accutane (Posted: 02/02/2001)
Acetaminophen (Posted: 08/16/2001)
Baycol (cerivastatin sodium tablets) (Posted: 06/26/2001, UPDATED 08/08/2001)
Cordarone I.V. (amiodarone HCl) (Posted: 06/06/2001)
Cydec (Posted: 01/12/2001)
Deltasone (prednisone) (Posted: 06/20/2001)
Diprivan (propofol) (Posted: 04/25/2001)
Exelon (Posted: 01/31/2001)
Gabitril (tiagabine HCl) (Posted: 08/24/2001)
Glyburide tablets (Posted: 09/24/2001)
Inapsine (droperidol) (Posted: 12/06/2001)
Lamictal (lamotrigine) (Posted: 12/06/2001)
Lamisil (Posted: 05/09/2001)
Lithobid (lithium carbonate) (Posted: 11/07/2001)
Medical Gases (Posted: 04/16/2001)
Miconazole (Posted: 03/05/2001)
MSM Eye Drops, MSM Eyes & Nasal Drops (Posted: 07/20/2001)
Naloxone Hydrochloride Injection (Posted: 04/06/2001)
Nutropin AQ (somatropin (rDNA origin) for injection) (Posted: 05/25/2001)
Orlaam (Levomethadyl Acetate Hydrochloride)(Posted: 04/20/2001)
OxyContin (oxycodone HCl)(Posted: 07/25/2001)
Pepcid (Posted: 03/27/2001)
Public Health Advisory: Cipro for Anthrax exposure (Posted: 10/19/2001)
Public Health Advisory: Doxycycline for Anthrax exposure (Posted: 10/18/2001)
Raplon (Posted: 03/29/2001)
Serostim (Posted: 01/23/2001) COUNTERFEIT UPDATE 05/25/2001
Sodium Phosphate (Posted: 11/01/2001)
Sporanox (Posted: 05/09/2001)
System TLC Mouth Rinse (Posted: 03/07/2001)
Taxotere (Posted: 03/28/2001)
Topamax (topiramate) (Posted: 09/26/2001)
Xeloda (capecitabine)(Posted: 11/01/2001)
Videx (didanosine)(Posted: 01/05/2001)
Weider's Eye Drops (Posted: 12/21/2001)
Zerit (stavudine)(Posted: 01/05/2001)
Zyvox (linezolid) (Posted: 03/02/2001)

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Other Products:

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Weider's Eyedrops

Audience: Healthcare professionals and Consumers
Aloe Flex Enterprises of Dickinson, Texas is recalling all lots of its 1 ounce bottles of "Weider's Eyedrops" due to potentially serious health risks associated with bacterial contamination. Samples analyzed by the Food and Drug Administration were found to contain bacteria including Acinetobacter calcoaceticus-baumannii, which in some cases can cause sight-threatening injury. The recalled "Weider's Eyedrops" and "Welder's Eyedrops" were sold over-the-counter in Dickinson, Texas.

[Dec 21, 2001 News Release - Aloe Flex Enterprises]

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VAQTA Hepatitis A Vaccine, Inactivated

Audience: Healthcare professionals
Merck & Co., Inc. is voluntarily recalling specified lots of VAQTA in prefilled syringes. Re-tests have revealed a decreased antigen content in some syringes below the established minimum specification. Patients who may have received doses from the indicated lots would have been vaccinated after May 29, 2001 with the adult formulation (50U/1 mL), and after August 9, 1999 with the pediatric/adolescent formulation, (25U/0.5 mL). Guidelines for antibody testing and revaccination of these patients are offered. See the "Dear Healthcare Professional" letter below for details.

[Dec 21, 2001 Letter - Merck & Co., Inc.]
[Dec 21, 2001 Table of Affected Lots - CBER recall page]

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Kava (Piper methysticum)

Audience: Gastroenterologists, Hepatologists, and healthcare professionals
FDA informs healthcare professionals that products containing herbal extracts of kava have been implicated in Europe in at least 25 cases of serious liver toxicity including hepatitis, cirrhosis, and liver failure. FDA requests the assistance of healthcare professionals in reviewing cases of liver toxicity to determine if any may be related to the use of kava-containing dietary supplements, and reporting such cases to MedWatch. To read the complete "Dear Healthcare Professional" letter, click on the link below.

[Dec 19, 2001 Letter - FDA / CFSAN] PDF Format

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Lamictal (lamotrigine)

Audience: Pharmacists and healthcare professionals
Continuing reports of dispensing errors due to name confusion involving LAMICTAL (lamotrigine) tablets, an antiepileptic drug, and other medications, most commonly Lamisil, lamivudine, Ludiomil, labetolol, and Lomotil. GlaxoSmithKline has developed materials and suggestions for pharmacists and physicians to help prevent dispensing errors.

[Dec 06, 2001 Letter (Physicians) - GlaxoSmithKline] PDF Format
[Dec 06, 2001 Letter (Pharmacists) - GlaxoSmithKline] PDF Format

Previous Safety Alerts
[June - August 2000 Health Professional letters]
[June 1998 Health Professional letter]

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Inapsine (droperidol)

Audience: Anesthesiologists and other healthcare professionals
FDA and Akorn Pharmaceuticals added a "black box" warning and strengthened the WARNINGS and PRECAUTIONS sections in the labeling for Inapsine, a tranquilizer used as a premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients. Cases of QT prolongation and/or torsades de pointes have been reported at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

[Dec 06, 2001 Letter - FDA]
[Dec 06, 2001 Talk Paper - FDA]

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Lipokinetix

Audience: Healthcare professionals, Consumers
The FDA is warning consumers to immediately stop use of the product Lipokinetix, marketed as a dietary supplement (for weight loss) by Syntrax Innovations, Inc. FDA has received multiple reports of persons who developed liver injury or liver failure while using Lipokinetix. The product contains norephedrine (also known as phenylpropanolamine or PPA), caffeine, yohimbine, diiodothyronine, and sodium usniate. FDA is also advising consumers to consult their physician if they are experiencing symptoms possibly associated with this product, particularly nausea, weakness or fatigue, fever, abdominal pain, or any change in skin color.

[Nov 20, 2001 Letter - FDA] PDF Format
[Nov 20, 2001 CFSAN Warnings and Safety Info webpage - FDA]

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Baxter Healthcare Dialyzers

Audience: Dialysis healthcare professionals, Risk Managers, Hospital Administrators
The FDA is investigating reports of over 50 patient deaths worldwide, including four in the United States, that may have been caused by certain dialyzers made by Baxter Healthcare Corporation, Deerfield, Ill. In mid-October, Baxter notified all of its customers to stop using these dialyzers immediately and return any inventory. The following dialyzers -- labeled either Althane or Baxter -- were recalled: Series A11, A15, A18 and A22; Series AF150, AF180 and AF220; Series AX1500 and AX2200.

[Nov 07, 2001 Letter - FDA]

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Lithobid (lithium carbonate): Expiration Dating Update

Audience: Pharmacists, Healthcare professionals
Expiration dating (or shelf life) for LITHOBID Slow Release Tablets was increased to 18 months. The recommendations previously made (Aug 8, 2000) to prescribe and dispense 30-day quantities of LITHOBID Slow Release Tablets are no longer relevant. Physicians and pharmacists may prescribe and fill prescriptions in their usual and customary manner.

[Nov 07, 2001 Letter - Solvay Pharmaceuticals]
[Aug 08, 2000 Letter - Solvay Pharmaceuticals; original notification]

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Computed Tomography for Pediatric and Small Adult Patients: Radiation Risks

Audience: Radiation Health Professionals, Risk Managers, Hospital Administrators
The FDA Center for Devices and Radiological Health issues a Public Health Notification to emphasize the importance of keeping radiation doses during CT procedures as low as reasonably achievable, especially for pediatric and small adult patients. The Notification stresses the importance of adjusting CT scanner parameters appropriately for each individual’s weight and size, and for the anatomic region being scanned.

[Nov 07, 2001 Public Health Notification - FDA] PDF Format

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Sodium phosphates oral solution

Audience: Healthcare professionals and patients
FDA issues a Science Background paper to provide additional safety information to health care practitioners and patients concerning dosage recommendations and the risks of sodium phosphate products. Clicking the link below will open a new window with the FDA CDER information page.

[Nov 01, 2001 Paper - FDA]

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Xeloda (capecitabine)

Audience: Oncologists, Pharmacists, and other healthcare professionals
FDA and Roche have added a BLACK BOX WARNING and strengthened the PRECAUTIONS section in the label for Xeloda, indicated for the treatment of colorectal and breast cancer. A clinically important XELODA-Warfarin drug interaction was demonstrated in a clinical pharmacology trial. Postmarketing reports have shown clinically significant increases in prothrombin time and INR in patients who were stabilized on anticoagulants at the time XELODA was introduced. Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. The Patient Package Insert was also revised to reflect this new safety information. New information is highlighted in the labels below.

[Nov 01, 2001 Label - (Revised sections only) - 25 Kb PDF file]
[Nov 01, 2001 Label - (Full Revised Label) - 1.77 MB PDF file]
[Nov 01, 2001 Label - (Revised Patient Package Insert) - 35 Kb PDF file]

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Remicade (infliximab) - Clinical Alert: Congestive Heart Failure

Audience: Rheumatologists, Gastroenterologists and other healthcare professionals
Centocor, in consultation with FDA, is alerting physicians to potential serious adverse effects of REMICADE in patients with CHF. Preliminary results of an ongoing phase 2 trial in patients with moderate to severe CHF demonstrated higher incidences of mortality and hospitalization for worsening heart failure in patients treated with REMICADE, especially those treated with the higher dose of 10 mg/kg. Based on these preliminary findings, and pending additional data, precautionary measures were recommended in a "Dear Healthcare Professional" letter.

[Oct 23, 2001 Letter - Centocor] PDF Format

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Remicade (infliximab) - Black Box Warning

Audience: Rheumatologists, Gastroenterologists and other healthcare professionals
FDA notifies health professionals that tuberculosis and other serious opportunistic infections, including
histoplasmosis, listeriosis, and pneumocystosis, have been reported in both the clinical research
and post-marking surveillance settings. Some of these infections have been fatal. Centocor has added a BOXED WARNING to the labeling for the product, and the WARNINGS and ADVERSE REACTIONS sections of the product labeling were revised.

[Oct 23, 2001 Letter - Centocor] PDF Format

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Public Health Advisory: Cipro for Anthrax Exposure

Audience: Health professionals and general public
FDA reminds all health professionals and the general public that Cipro is approved for the inhaled form of anthrax after an individual has been exposed. Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established, except for use in inhalational anthrax (post-exposure). The FDA Center for Drug Evaluation and Research has posted a comprehensive web page on the use of Cipro for inhalational anthrax.

[Oct 19, 2001 Message to Health Professionals - FDA]
[Oct 19, 2001 Information for Consumers: Questions and Answers - FDA]
[Oct 19, 2001 Comprehensive Cipro Information Page- FDA/CDER]

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Public Health Advisory: Doxycycline for Anthrax Exposure

Audience: Health professionals and general public
FDA reminds all health professionals and the general public that Doxycycline is approved for the treatment of anthrax in all its forms. The FDA is providing additional information concerning the dosing regimen for the treatment of anthrax, including cutaneous and inhalation anthrax (post-exposure). The currently recommended dosage regimen of doxycycline for severe disease is 100 mg every 12 hours for adults and 1mg per pound (2.2mg per kilogram) every 12 hours for children less than 100 pounds. These dosage regimens are appropriate for use in patients who have been exposed to anthrax (Bacillus anthracis) regardless of the route of exposure.

[Oct 18, 2001 Public Health Advisory - FDA]

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Topamax (topiramate)

Audience: Neurologists, Ophthalmologists, and other Healthcare professionals
FDA and Ortho-McNeil have strengthened the WARNINGS and PRECAUTIONS sections in the label of Topamax Tablets and Sprinkle Capsules, indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with seizure disorders. Cases of secondary angle closure glaucoma characterized by ocular pain, accute myopia, and increased intraocular pressure were reported in pediatric and adult populations. The primary treatment is discontinuation of Topamax. If left untreated, serious sequelae, including permanent vision loss, may occur. Patients taking Topamax should be told to seek immediate medical attention if they experience blurred vision or periorbital pain.

[Sept 26, 2001 Letter - Ortho-McNeil] PDF Format
[Oct 1, 2001 Label - (Revised sections only) - 15k PDF file]
[Oct 1, 2001 Label - (Full revised label) - 98k PDF file]

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Glyburide Tablets

Audience: Pharmacists, Heathcare professionals
FDA announces a voluntary recall of Micronase lots 84DWB (1.25 mg, bottle of 100); 91DYR (2.5 mg, bottle of 100); 67FPP (5 mg, bottle of 100); and 42 different lots of Greenstone Brand Glyburide Tablets. Fungal organisms have been detected in some lots of MICRONASE and Greenstone Brand Glyburide Tablets, traced to a raw material used in the formulation. Details of the recalls are listed in the links below.

[Sept 24, 2001 Letter - Pharmacia Corporation]
[Sept 24, 2001 Letter - Greenstone]

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St. Gobain Desmarquest Zirconia Ceramic Femoral Head

Audience: Orthopedic Surgeons
Healthcare professionals are notified of a voluntary recall of the unimplanted inventory of nine batches of zirconia ceramic femoral heads manufactured by a French manufacturer, and by U.S. manufacturers that have included these components in their hip prostheses. The component was recalled by its French manufacturer St. Gobain Desmarquest August 14 because it was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted.

[Sept 17, 2001 Talk Paper - FDA]
[Sept 17, 2001 Background Information - FDA]

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Gabitril (tiagabine HCl)

Audience: Neurologists and other health professionals
Healthcare professionals are notified that Cephalon, Inc. is removing the word "Filmtab" from the GABITRIL product name. The change in the GABITRIL product name will be reflected in all related documents (e.g., prescribing information, and packaging material). In addition, the appearance of GABITRIL Tablets has been changed to replace the Abbott logo with the Cephalon logo.

[August 24, 2001 Letter - Cephalon, Inc.]

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Neumega (oprelvekin)

Audience: Oncologists, particularly Pediatric Oncologists
Wyeth-Ayerst notifies health professionals of safety information for NEUMEGA use in the pediatric population. Preliminary data from a safety and pharmacokinetic study in 47 children has identified papilledema as a dose-limiting adverse reaction in the pediatric population. There are no controlled clinical studies that have established a safe and effective dose of NEUMEGA in children. Therefore, the administration of NEUMEGA in children, particularly those under 12 years of age, should be restricted to controlled clinical trial settings with closely monitored safety assessments. See the full letter below for further details.

[August 24, 2001 Letter - Wyeth-Ayerst] PDF Format (348Kb)

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Acetaminophen

Audience: Pharmacists and other health professionals
Perrigo Company announced that, in cooperation with the FDA, it is conducting a recall of four-ounce bottles of cherry-flavored pain reliever suspension liquid with Lot Number 1AD0228. This lot may contain an excess of up to 29 percent over the labeled amount of acetaminophen. The product is being recalled because overdoses of acetaminophen can lead to severe health problems including liver toxicity and liver failure. The product, which is used to treat headaches and fevers in children, was sold under the Good Sense®, Hy-Vee®, and Kroger® labels throughout the United States.
[August 16, 2001 Recall Notice - FDA]

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Transfusion Related Acute Lung Injury (TRALI)

Audience: Health Professionals, particularly Respiratory Specialists
FDA alerts health professionals to the risk of Transfusion Related Acute Lung Injury (TRALI) in patients who receive blood products, particularly plasma-containing products. TRALI is a serious pulmonary syndrome that can lead to death if not recognized and treated appropriately. Recognition of symptoms and immediate treatment are imperative.

[October 19, 2001 - Letter - FDA]
[August 08, 2001 Letter - FDA]

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Baycol (cerivastatin)

Audience: Health Professionals and Consumers
Bayer announced the withdrawal of all dosages of its cholesterol-lowering drug with the brand names Baycol/Lipobay (active ingredient: cerivastatin), due to increasing reports of side effects involving muscular weakness (rhabdomyolysis). Fatal rhabdomyolysis associated with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug.

[August 08, 2001 Letter - Bayer] PDF Format
[August 08, 2001 Talk Paper - FDA]
[August 08, 2001 Baycol Q&A Web Page - FDA]

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OxyContin (oxycodone HCl)

Audience: Health Professionals and Consumers
FDA and Purdue Pharmaceuticals have strengthened the warnings and precautions sections in the labeling of OxyContin, a narcotic drug approved for the treatment of moderate to severe pain, because of continuing reports of abuse and diversion. The changes are intended to reinforce proper prescription practices and increase physician focus on the potential for abuse, misuse, and diversion. Revisions to the label can be seen by clicking on the links below; revisions are highlighted.

[July 25, 2001 Letter - Purdue Pharma] PDF format
[July 25, 2001 Talk Paper - FDA]
[July 25, 2001 Questions and Answers - FDA]
[July 25, 2001 Label (revised sections only) - 99k PDF file]
[July 25, 2001 Label (Full revised label) - 240k PDF file]

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MSM Eye Drops and MSM Eyes & Nasal Drops

Audience: Health Professionals and Consumers
Ultra Botanicals, Inc. of Los Angeles, CA, is recalling all lots of its 1 ounce bottles of "MSM Eye Drops" and "MSM Eyes & Nasal Drops" due to potentially serious health risks associated with bacterial contamination. Samples analyzed by FDA were found to contain Pseudomonas mendocina and Klebsiella pneumoniae, bacteria that in some cases can cause sight-threatening injury.

[July 20, 2001 News Release - FDA]

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Medical Gas Misconections -- Public Health Advisory

Audience: Hospital Administrators, Risk Managers, Respiratory Specialists
The FDA Center for Devices and Radiological Health (CDRH) issued a Public Health Advisory alerting healthcare professionals to the potential for patient injury when cryogenic vessels containing medical gas are misconnected to oxygen delivery systems. Misconnections cause patients who should receive medical oxygen to receive another gas, such as nitrogen, instead. Over the past four years, FDA has received reports of seven deaths and fifteen injuries associated with medical gas misconnections that occurred in acute care and nursing home settings.
[July 20, 2001 Public Health Advisory - FDA]

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Baycol (cerivastatin sodium tablets)

Audience: Primary Care Physicians and other health professionals
Bayer Corporation has notified healthcare professionals of changes in the prescribing information for Baycol, providing more specific guidance on initiating therapy and dose adjustment in order to reduce the risk of myopathy and rhabdomyolysis.
[June 26, 2001 Letter - Bayer Corp.] PDF version
[June 26, 2001 Revised Label]

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Deltasone tablets (prednisone)

Audience: Pharmacists and other health professionals
Pharmacia Corporation announced a recall in the United States of its 500 count bottles of DELTASONE Tablets (prednisone tablets, USP), 10 mg, Lot number 29DRB. The recall is based on one report from a pharmacist that a bottle labeled as DELTASONE Tablets, 10 mg, actually contained DELTASONE Tablets, 5 mg. While this may have been the only mislabeled bottle, other mislabeled bottles may have been distributed. No other lots or countries are affected by this recall.
[June 20, 2001 Letter - Pharmacia Corp.]

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Cordarone I.V. (amiodarone HCl)

Audience: Neonatologists, Pediatricians, Cardiologists, and other healthcare professionals
Wyeth-Ayerst Pharmaceuticals notified health care professionals of two safety-related changes to the Cordarone IV (amiodarone HCl) prescribing information, describing potentially fatal or developmental side effects associated with use of this product in neonatal and infant pediatric patients. Wyeth-Ayerst Pharmaceuticals is aware that Cordarone IV is used off-label to treat arrhythmias in pediatric patients. The safety and efficacy of amiodarone IV in the pediatric population have not been established; therefore, its use in pediatric patients is not recommended.
[June 08, 2001 Letter - Wyeth-Ayerst Pharmaceuticals]

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Nutropin AQ (Somatropin)

Audience: Healthcare professionals, pharmacists, wholesalers
Genentech, Inc. recently became aware of the existence in the U.S. of a counterfeit drug product labeled as Nutropin AQ® 10 mg vials in 6-pack boxes. The Genentech web page referenced below includes detailed descriptions, along with comparison photos of the authentic and the counterfeited product.
[May 25, 2001 Counterfeit Alert - Genentech Inc. web page]

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Neupogen (Filgrastim)

Audience: Oncologists and other healthcare professionals, pharmacists, wholesalers
Amgen Inc. recently became aware of the existence in the U.S. of a counterfeit drug product labeled as Neupogen® 300 mcg vials in ten- pack boxes. In cooperation with the FDA, Amgen is informing patients, physicians, pharmacies, and wholesalers about this serious health risk. The Amgen web page referenced below includes detailed descriptions, along with comparison photos of the authentic and the counterfeited product.
[May 10, 2001 Counterfeit Alert - Amgen Inc. web page]

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Lamisil (terbinafine hydrochloride)
Sporanox (itraconazole)

Audience: Dermatologists and other healthcare professionals
FDA is issuing a public health advisory concerning Sporanox and Lamisil, systemic drug therapies to treat onychomycosis (fungal nail infections). Healthcare professionals are notified of the possible association of serious cardiac adverse events with the administration of Sporanox and hepatic adverse events with the administration of both Sporanox and Lamisil. New labeling for both Sporanox and Lamisil recommends that healthcare providers obtain nail specimens for laboratory testing prior to prescribing the medications for onychomycosis to confirm the diagnosis. FDA's concerns do NOT apply to the over-the-counter versions of Lamisil, which are topical creams.
[May 11, 2001 Letter - Novartis Pharmaceuticals Corp.]
[May 09, 2001 Letter - Janssen Pharmaceutica Products, L.P.]
[May 09, 2001 Public Health Advisory - FDA]
[May 09, 2001 Talk Paper - FDA]
[May 09, 2001 Questions and Answers - FDA]
[May 09, 2001 Revised Sporanox Capsules Label, April 2001 - Janssen Pharmaceutica Products, L.P.]
[May 09, 2001 Revised Lamisil Tablets Label - Novartis]

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Roferon-A (Interferon alfa 2a, recombinant)

Audience: Oncologists and Other Healthcare professionals
FDA and Roche have added a BOXED WARNING and strengthened the WARNINGS section of the prescribing information to advise healthcare professionals of neuropsychiatric, autoimmune, ischemic, and infectious disorders in patients taking Roferon-A. Specific requirements for monitoring patients taking Roferon-A have been added. This information has been added to the product information for all alpha interferons.

[May, 2001 Letter - Roche] 134 kb PDF Format
[May, 2001 Revised Package Insert - Roche]

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Ancure Endograft System and AneuRx Stent Graft System

Audience: Vascular Surgeons, Hospital operating room personnel
The FDA Center for Devices and Radiological Health (CDRH) has issued a public health notification regarding serious problems that have occurred with these two endovascular prosthetic graft devices, used to treat infrarenal Abdominal Aortic Aneurysm (AAA). The Notification letter provides a brief background on endovascular repair of AAA, lists the specific problems that occurred with the devices, and makes recommendations concerning their continued use. (Clicking the link below will launch a new browser window displaying the CDRH web page or PDF format letter)
[April 30, 2001 Letter - FDA] PDF Format

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Single Use Medical Devices (SUDs)

Audience: Hospital Administrators and Hospital Risk Managers
The FDA Center for Devices and Radiological Health has sent a letter to all U.S. hospitals reminding them about its intention to enforce certain requirements regarding the reprocessing of single-use medical devices (SUDs) for later use on patients. The letter provides a timetable and specifies actions that may be taken against hospitals that do not comply.
[April 25, 2001 Letter - FDA]
[April 25, 2001 CDRH Reuse Home Page - FDA]

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Diprivan (propofol)

Audience: Pediatricians and Pediatric ICU healthcare professionals
The FDA has determined that there may be important safety concerns when propofol, marketed by AstraZeneca as DIPRIVAN (propofol) Injectable Emulsion, is used for sedation in the Intensive Care Unit (ICU) in pediatric patients. Healthcare professionals are reminded that propofol is not approved in the U.S. for sedation in pediatric ICU patients.
[April 25, 2001 Letter - AstraZeneca Pharmaceuticals] PDF Format

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Orlaam (Levomethadyl Acetate Hydrochloride)

Audience: Addiction treatment specialists
Healthcare professionals are notifed about serious cardiac adverse events, including QT prolongation and severe cardiac arrhythmia, associated with Orlaam (levomethadyl acetate HCl), a drug for opiate addiction treatment. Roxane Laboratories, Inc. has made important changes to the Orlaam label, adding a black box warning, and changes to the precautions, contraindications, and drug interactions sections.

[April 19, 2001 Letter - Roxane Laboratories, Inc] PDF Format
[April 20, 2001 Talk Paper - FDA]

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Medical Gases

Audience: hospital and nursing home management and staff, particularly anesthesia professionals
FDA alerts hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups. FDA has received reports from hospitals and nursing homes involving 7 deaths and 15 injuries to patients who were thought to be receiving medical grade oxygen, but were receiving a different gas (e.g., nitrogen) that had been mistakenly connected to the oxygen supply system. This guidance makes recommendations about procedures that will reduce the chance of error and subsequent harm. To access the complete FDA Guidance document, go to:
http://www.fda.gov/cder/guidance/4341fnl.htm

 

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Aristolochic Acid

Audience: Healthcare professionals, particularly Urologists/Nephrologists, and consumers
FDA has issued a Consumer Advisory and sent updated letters to industry and health professionals to communicate concern about dietary supplements and botanical products, often marketed as "traditional medicines", that may contain aristolochic acid. Aristolochic acid has been associated with nephropathy leading to end stage renal disease and with urological malignancies. Visit the FDA Center for Food Safety and Applied Nutrition (CFSAN) Aristolochic Acid web page.

[April 11, 2001 Consumer Advisory - FDA]
[April 4, 2001 Letter to Health Professionals - FDA]
[April 9, 2001 Updated Letter to Industry - FDA]
[Updated April 9, 2001 Listing of Botanical Ingredients of Concern - FDA]
[April 9, 2001 Botanical Products Determined by FDA to Contain Aristolochic Acid - FDA]

Product Recalls
[August 6, 2001 Recall of capsules containing Akebia Trifoliata Caulis (Mu Tong) and Asarum Sieboldii Herba cum Radix (Xi Xin); - Pacific BioLogic Co. Press Release]
[May 24, 2001 Recall of Joint Ease & Joint Comfort Complex - Vital Nutrients/RHG Press Release]
[January 25, 2001 Recall of Neo Concept Aller Relief - BMK International Press Release]
[November 21, 2000 Recall of Meridian Circulation and Quell Fire - East Earth Herb Inc. Press Release]

Past FDA Actions:
[May 16, 2000 Letter to Industry - FDA]
[May 31, 2000 Letter to Health Care Professionals (also in Chinese) - FDA]

 

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Naloxone Hydrochloride Injection

Audience: Hospital pharmacists, anesthesia providers and other healthcare professionals
Health care professionals are notified of a shortage of Naloxone HCl injection, a narcotic antagonist. This appears to be a temporary situation of two to three months in length. FDA has identified a temporary alternate supplier of Naloxone Hydrochloride Injection, USP in 0.4 mg/mL ampoules (1mL) and vials (10mL), as well as 1 mg/mL vials (2mL) effective April 4, 2001. Physicians and hospitals will be able to obtain this product via overnight delivery. This temporary program will not cover the pediatric strength of product (0.02 mg/mL). Supplies of this strength are available, but limited. FDA will continue to monitor this important health issue until its resolution. Updates on this product and further information on the FDA Drug Shortage program can be found at www.fda.gov/cder/drug/shortages.

[April 6, 2001 (Drug Shortage Alert) - FDA]

 

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Capture-R Ready Screen & Capture-R Ready ID

Audience: Blood Bank personnel and other healthcare professionals
Voluntary recall of specific lots of Capture-R Ready-Screen and Capture-R Ready-ID Solid Phase Test Wells, manufactured by Immucor, Inc. The recalled products are used by blood bank laboratories to screen for and identify unexpected antibodies. The recalling firm received complaints involving situations in which testing with these lots failed to detect some examples of anti-Fy^a. Product lots involved in these complaints include Capture-R Ready-Screen (I and II), Lots X2701, X2801 and X29; Capture-R Ready-Screen (4), Lots G0101, G02, G03; Capture-R Ready-Screen (Pooled Cells), Lots N42 and CW021; and Capture-R Ready-ID, Lots ID48 and ID49. Capture-R Ready-Screen Lot X29 has been potentially implicated in a transfusion reaction. No other blood group system antibodies have been associated with these complaints.

 

[March 29, 2001 (Letter) - Immucor, Inc.] PDF Format
[March 30, 2001 FDA CBER Notice - Immucor, Inc.]

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Raplon (rapacuronium bromide)

Audience: hospital pharmacists, anesthesia professionals, wholesalers
Organon Inc. initiated a voluntary recall of Raplon® (rapacuronium bromide) for injection. Several serious adverse events, including bronchospasm and unexplained fatalities, were reported during postmarketing surveillance (in each of these cases the cause was unknown, as there were multiple drugs administered and other conditions present). The posted letter is part of a package distributed by the manufacturer.

 

[March 29, 2001 (Letter) - Organon, Inc.] PDF Format
[March 29, 2001 (Talk Paper) - FDA]

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Taxotere (docetaxel)

Audience: Wholesalers, hospital pharmacists, and oncology healthcare professionals
Aventis Pharmaceuticals has initiated a voluntary recall of Taxotere® (docetaxel) for Injection Concentrate 20-mg active and diluent vials. The lot numbers for this recall are: 0P273 (active) which was packaged together with diluent vials with the following lot numbers: 0T446 (diluent) or 0T449 (diluent). It has been determined that the Taxotere 20mg vial containing the active ingredient may have inadvertently been labeled as a “diluent” vial. Aventis has received one product complaint related to this mislabeling.

 

[March 28, 2001 (Letter to Healthcare Professionals) - Aventis Pharmaceuticals] PDF Format
[March 28, 2001 (Letter to Wholesalers) - Aventis Pharmaceuticals] PDF Format

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Pepcid (famotidine)

Audience: Healthcare Professionals, particularly those caring for elderly patients in nursing home settings
Healthcare professionals are notified about the need for dosage adjustments for patients with moderate renal insufficiency [creatinine clearance <50ml/minute]. The previous labeling recommended adjustments for severe insufficiency only [creatinine clearance <10ml/minute].

 

[March 23, 2001 (Summary)]
[March 23, 2001 (Changes to Pepcid label - PDF Format) ]

• PRECAUTIONS, DOSING AND ADMINISTRATION, and PHARMACOLOGY sections revised; changes highlighted

[March 23, 2001 (Full, revised Pepcid label - PDF Format) - Merck & Co.]

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Healthcare providers reminded to closely monitor patients on arsenic trioxide

CTI has issued a "Dear Health Care Provider" letter reminding clinicians that QTc prolongation with torsade de pointes arrhythmia and sudden death have been associated with the use of arsenic trioxide. An article published recently in Blood (Unnikrishnan, et al, 1 March 2001;97:1514–1516) describes prolonged QT interval and torsade de pointes in 3 patients being treated with arsenic trioxide for acute myeloid leukemia (AML). The arsenic trioxide used in the reported study was not Cell Therapeutics’ Trisenox™ (arsenic trioxide) injection. The current Trisenox label emphasizes the importance of ECG and electrolyte monitoring prior to and during therapy in patients given arsenic trioxide.

 

[March 19, 2001 (Letter - PDF Format) - Cell Therapeutics, Inc.]

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Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers

Potential for harmful lead exposure from dental films stored in containers lined with unpainted lead. There may be hundreds of these lead-lined boxes currently being used to store dental films. Some of them may have been in use for decades. Most of these boxes are the size and shape of shoe-boxes, made of wood, and lined with lead that has apparently not been painted or coated.

 

[March 14, 2001 (Public Health Notification Letter) - FDA]

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System TLC Mouth Rinse 4 oz

Lot number 0049001 recalled due to contamination with Burkholeria cepacia. Other lots recalled because they do not meet the manufacturers product specifications.

 

[March 6, 2001 (Recall Notice) - Chester Labs]

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Miconazole

Women who take a warfarin anticoagulant and use miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time.

 

[March 5, 2001 (Science Background) - FDA]
[March 5, 2001 (Talk Paper) - FDA]

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Zyvox (linezolid)

Myelosuppression (including anemia, leukopenia, pancytopenia and thrombocytopenia) has been reported in patients receiving linezolid. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with chronic infection who have received previous or concomitant antibiotic therapy.

 

[March 2, 2001 (Letter - PDF Format) - Pharmacia, Corp.]

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Epogen and Neupogen (Epoetin alfa and Filgrastim)

Three reported incidents of product tampering. Specifically, the flip caps from the tops of eight vials from different lots of EPOGEN and NEUPOGEN were removed and the contents of the vials extracted. The contents were replaced with varying amounts of an aqueous solution and the vials were resealed in an apparent effort to conceal product theft.

 

[February 15, 2001 (Letter - PDF Format) - Amgen, Inc.]

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Accutane (isotretinoin)

Manufacturer releasing two new communication tools for this acne treatment: a Medication Guide and an Informed Consent for all Accutane patients.

 

[January 22, 2001 (Letter) - Roche Laboratories, Inc.]
[January 22, 2001 (Medication Guide) - Roche Laboratories, Inc.]
[January 22, 2001 (Informed Consent/Patient Agreement) - Roche Laboratories, Inc.] PDF Format

• Supplements consent form in Accutane Label, May 2000

[September 2000 (Advisory Committee Meeting Briefings)

• Background info on pregnancy, psychiatric events risk management issues.

[May, 2000 Accutane Label] PDF Format

• WARNINGS, PRECAUTIONS, and ADVERSE EVENTS sections extensively revised.

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Exelon (rivastigmine tartrate)

Changes to Prescribing Information for Exelon. The changes provide guidelines for reinitiating therapy in patients who have interrupted treatment with Exelon, to reduce the risk of severe vomiting.

 

[January 31, 2001 (Letter) - Novartis Pharmaceuticals]

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Neo Concept Aller Relief

Voluntary recall by manufacturer BMK International after notification from the FDA that the product contains trace amounts of aristolochic acid, a potent carcinogen and nephrotoxin found in certain plants and botanicals. (The link opens a new browser window with the manufacturer's press release)

 

[January 25, 2001 (Press Release)]

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Serostim

Serono, Inc. issued a warning upon discovery of counterfeit versions of Serostim, a drug used to treat AIDS wasting. The counterfeit product is of unknown safety and efficacy and may pose a health risk to patients. The counterfeit product has been packaged to appear as a drug product with lot numbers MNK612A and MNH605A and is readily distinguishable from authentic Serostim by features specified in the manufacturers press release.

 

[May 17, 2001 (Letter) - Serono, Inc.] PDF Format
[May 17, 2001 (Press Release) - Serono, Inc.] PDF Format
[January 23, 2001 (Press Release) - Serono, Inc.]

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Cydec Pediatric Drops

Great Southern Laboratories initiated a Class I recall upon learning that the outer carton in which each Cydec Drops bottle was packaged from Lot #02950 bore an incorrect dosage correlation chart. The chart incorrectly equates a dropperful and partial dropperfuls to a teaspoonful and partial teaspoonfuls.

 

[January 12, 2001 (Press Release) - Great Southern Laboratories]

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Zerit (stavudine) and Videx (didanosine)

Fatal lactic acidosis has recently been reported in pregnant women treated throughout gestation with the combination of stavudine and didanosine. Based on these cases, the combination of Zerit (stavudine) and Videx (didanosine) should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk, such as when there are few remaining treatment options.

 

[January 5, 2001 (Letter) - Bristol-Myers Squibb]
[January 5, 2001 (Letter) - PDF Format - Bristol-Myers Squibb]
[January 5, 2001 (Talk Paper) - FDA]
[Revised labels for Zerit; Videx; and Videx EC - PDF Format ]

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