FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website
FDA Home Page | About Medwatch | Contact MedWatch | MedWatch Partners
 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program


2003 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

How to Find a Safety Summary

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

    Biologics - Dietary Supplements - Drugs - Medical Devices - Other

    -- or --

  2. 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

Get Acrobat Reader

The Adobe Acrobat [pdf] file 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:

Avonex (Interferon beta-1a) (Posted 3/14/2003)
Procrit (epoetin alfa) (Posted 3/14/2003)
Zenapax (daclizumab) (Posted 8/20/2003)

Return to Top


Dietary Supplements:

Ancom Anti-Hypertensive Compound Tablets (Posted 1/17/2003; UPDATED 3/18/2003)
Best Life Viga Tablets (Posted 5/29/2003)
Health Nutrition (RMA Labs) Viga or Viga for Women Tablets (Posted 6/27/2003)
Vinarol Tablets (Posted 4/9/2003)

Return to Top


Drugs:

Acetaminophen, Dixon's 325 mg Tablet, Regular Strength (Posted 12/8/2003)
Advair Diskus (fluticasone propionate and salmeterol inhalation powder) (Posted 8/15/2003)
Arava (leflunomide) (Posted 11/20/2003)
Genotropin (somatropin [rDNA origin] for injection) (Posted 7/25/2003)
Keppra (levetiracetam) Tablets and Oral Solution (Posted 10/8/2003)
Lariam (mefloquine hydrochloride) (Posted 10/10/2003)
Lindane (gamma-hexachlorocyclohexane)
(Posted 3/28/2003)
Lipitor (atorvastatin) (Posted 5/29/2003, UPDATE June 3, 2003, June 11, 2003)
Nortrel 7/7/7 - 28 Day Oral Contraceptive (norethindrone and ethinyl estradiol tablets, USP) (Posted 7/11/2003)
Orlaam (Levomethadyl Acetate Hydrochloride) (Posted 9/9/2003)
Permax (pergolide mesylate) (Posted 12/22/2003) New
Permax (pergolide mesylate) (Posted 2/24/2003)
Prandin (repaglinide) (Posted 9/29/2003)
Premarin (conjugated estrogens tablets, USP) (Posted 1/8/2003)
Premphase (conjugated estrogens/medroxyprogesterone acetate tablets) (Posted 1/8/2003)
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) (Posted 1/8/2003)
Public Health Advisory - Suicidality in Pediatric Patients Treated with Antidepressants for Major Depressive Disorder (Posted 10/27/2003)
Pyrazinamide plus Rifampin for Treatment of Latent Tuberculosis Infection (LTBI) (Posted 8/12/2003)
Rapamune (sirolimus) (Posted 2/20/2003)
Reyataz (atazanavir sulfate) (Posted 8/20/2003)
Rifampin plus Pyrazinamide for Treatment of Latent Tuberculosis Infection (LTBI) (Posted 8/12/2003)
Risperdal (risperidone) (Posted 4/25/2003)
Roxanol (morphine sulfate) Concentrated Oral Solution (Posted 10/8/2003; UPDATED 10/29/2003)
Serevent Inhalation Aerosol and Diskus (salmeterol xinafoate) (posted 8/15/2003)
Serevent (salmeterol xinafoate) (Posted 1/23/2003)
Serzone (nefazodone HCl) (Posted 2/13/2003)
Tamiflu (oseltamivir phosphate) Capsules and for Oral Suspension (Posted 1/2/2004) New
Topamax (topiramate) Tablets/Sprinkle Capsules (Posted 12/30/2003) New
Topamax (topiramate) Tablets/Sprinkle Capsules (Posted 7/10/2003)
Ultane (sevoflurane) (Posted 11/20/2003)
Valcyte (valganciclovir HCl tablets) (Posted 10/22/2003)
Viread (tenofovir disoproxil fumarate) (Posted 10/21/2003)
Ziagen (abacavir) (Posted 7/31/2003)

Return to Top


Medical Devices:

AneuRx Stent Graft System (Posted 12/17/2003)
CoaguChek PT test strips (Posted 10/9/2003)
ComfortGel Nasal Masks (Posted 12/4/2003)
CYPHER Sirolimus-Eluting Coronary Stent (Posted 7/9/2003)
CYPHER Sirolimus-Eluting Coronary Stent (Posted 10/29/2003)
Esprit Ventilator Model V1000 (Posted 7/3/2003)
Hospital Bed Fires (Posted 12/22/2003) New
INTERGEL Adhesion Prevention Solution (Posted 4/16/2003)
Misys Healthcare Systems laboratory information system software (Posted 10/27/2003)
ProbeTec ET Instrument (Posted 8/21/2003)
Prolene Polypropylene Mesh (Posted 11/5/2003, UPDATED 12/19/2003)
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use (Posted 9/30/2003)

Return to Top


Other Products:

FD&C Blue No. 1 (Blue 1) in enteral feeding solutions (Posted 9/30/2003)

Return to Top


2003 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 [pdf] file = 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


Tamiflu (oseltamivir phosphate) Capsules and for Oral Suspension
Audience: Pediatricians, Primary Care Providers, and other Healthcare professionals
Roche Laboratories and FDA notified healthcare professionals of new preclinical safety data that have implications for the use of Tamiflu in very young children. Preclinical findings in juvenile rats have raised concerns regarding the use of Tamiflu in infants less than 1 year of age. A single dose of 1000 mg/kg oseltamivir phosphate (about 250 times the recommended dose in children) in 7-day-old rats resulted in deaths associated with levels of oseltamivir phosphate in the brain approximately 1500 times those seen in adult animals. It is likely that these high exposures are related to an immature blood-brain barrier. The clinical significance of these preclinical data to human infants is uncertain. Given the uncertainty in predicting the exposures in infants with immature blood-brain barriers, it is recommended that Tamiflu not be administered to children younger than 1 year.

[December 2003 Letter - Roche Pharmaceuticals] Adobe Acrobat [pdf] file
[October 2001 Package Insert - Roche Pharmaceuticals] Adobe Acrobat [pdf] file

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


Topamax (topiramate) Tablets/Sprinkle Capsules
Audience: Neurologists and other Healthcare professionals
Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS sections of the prescribing information, notifying healthcare professionals that Topamax causes hyperchloremic, non-anion gap metabolic acidosis (decreased serum
bicarbonate). Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended.

[December 2003 Letter - Ortho-McNeil] Adobe Acrobat [pdf] file
[December 2003 Full, revised label, highlighted - Ortho-McNeil] Adobe Acrobat [pdf] file

Previous MedWatch alert

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


Hospital Bed Fires
Audience: Hospital risk managers and administrators
The FDA Center for Devices and Radiological Health issued a Public Health Notification with information on reports of fires involving electrically powered hospital beds since 1993. The notification includes a list of safety tips. The safety tips apply to both electrically powered and manual healthcare beds, and to adjustable medical beds. They may be particularly useful for older model beds. One list is intended for the clinical staff and the other for staff responsible for bed maintenance.

[December 18, 2003 Public Health Notification - FDA]

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


Permax (pergolide mesylate)
Audience: Neurological and other healthcare professionals
FDA and Lilly modified the WARNINGS and PRECAUTIONS sections to inform healthcare professionals of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with Permax, a dopamine agonist, indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease. Many patients who have fallen asleep have perceived no warning of somnolence. Healthcare professionals should be alerted to the potentially serious risks associated with these events and should carefully evaluate their patients for the presence of somnolence.

[December 15, 2003 Letter - Eli Lilly] Adobe Acrobat [pdf] file
[October 2003 Label, highlighted - Eli Lilly] Adobe Acrobat [pdf] file

Previous MedWatch alerts:
[February 2003 Letter - Lilly]

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


AneuRx Stent Graft System
Audience: Interventional Radiologists, Cardiovascular healthcare professionals and Risk Managers
The FDA Center for Devices and Radiological Health issued a Public Health Notification with updated information on the mortality risks associated with the AneuRx Stent Graft System, when implanted for the prevention of abdominal aortic aneurysm rupture. This information was based on an analysis of the extension of an investigational premarket study, which began in March of 1996, with a subgroup of 942 patients followed through October 24th, 2002. Based on the findings of the study, it was recommended that the AneuRx Stent Graft be used only in patients who meet the appropriate risk-benefit profile and who can be treated in accordance with the instructions for use.

[December 17, 2003 Public Health Notification - FDA]

Previous MedWatch alerts:
[April 30, 2001 Letter - FDA] PDF Format Adobe Acrobat [pdf] file

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


Acetaminophen, Dixon's 325 mg Analgesic Tablets
Audience: Pharmacists and consumers
Magno-Humphries, Inc., in cooperation with the FDA, voluntarily recalled one lot (504 bottles) of Dixon's®, APAP Acetaminophen 325 mg Analgesic Tablets, an over-the-counter drug product sold in 100 Tablet bottles with lot number 319687, Expiration Date 03/05. The tablets contained in the mislabeled bottles are 500 mg Acetaminophen, instead of 325 mg Acetaminophen. Overdoses of acetaminophen can lead to severe health problems including liver toxicity and liver failure. The acetaminophen was sold under the Dixon's® label at retail stores and pharmacies nationwide beginning in August 2003.

[December 4, 2003 Recall Notice - FDA]

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


ComfortGel Nasal Masks
Audience: Hospital Risk Managers, respiratory care professionals
The FDA Center for Devices and Radiological Health posted a Class I recall notice for the ComfortGel Nasal Masks by Respironics, Inc. Murrysville, PA. These masks are used on patients being treated for obstructive sleep apnea or for respiratory failure and are used in conjunction with CPAP devices. These devices work by exhausting all of the exhaled CO2 out of an exhalation port built into the mask. The user instructions inform the patient that the mask contains an exhalation port and does not require the use of a separate exhalation device. However, the product was distributed without the exhalation port. Without the port in the breathing circuit, it is likely that the patient will experience increased CO2 re-breathing and associated oxygen deficiency. In some cases, suffocation may result.

[December 4, 2003 Device Recall - FDA]

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


Arava (leflunomide)
Audience: Rheumatoid specialists and other healthcare professionals
Aventis Pharmaceuticals and FDA updated the prescribing information for Arava (leflunomide), indicated for the treatment of active rheumatoid arthritis. In postmarketing experience worldwide, rare, serious hepatic injury, including cases with fatal outcome, have been reported during treatment with Arava. Most cases occurred within 6 months of therapy and in a setting of multiple risk factors for hepatotoxicity. Rare postmarketing reports of severe infections, including sepsis, which may be fatal, were also received. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which, in addition to rheumatoid disease, may predispose patients to infection.

[October, 2003 Letter - Aventis]
[June, 2003 Revised, highlighted label - Aventis]

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


Ultane (sevoflurane)
Audience: Anesthesia healthcare professionals
Abbott Laboratories issued a "Dear Healthcare Professional" letter concerning reports of fire or extreme heat in the respiratory circuit of anesthesia machines when Ultane is used in conjunction with a desiccated CO2 absorbent, which can result in patient injury. Ultane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. The letter provided suggestions to reduce the risk of occurrence of these adverse events. Abbott, in collaboration with the FDA, is investigating the causative and preventive factors surrounding the issues of fire, extreme heat, and potential breakdown products associated with the use of Ultane and desiccated CO2 absorbents.

[November 17, 2003 Letter - Abbott]

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


PROLENE Polypropylene Mesh
Audience: Surgeons, surgical staff, hospital risk managers, and other healthcare professionals
(November 3, 2003) Ethicon, Inc. issued an alert about counterfeit polypropylene mesh product labeled as PROLENE. PROLENE mesh is a nonabsorbable mesh used in the repair of hernias and other fascial deficiencies. Physicians, nurses and all other healthcare professionals should carefully examine all PROLENE flat mesh product and not use any product that is suspected to be counterfeit. Ethicon issued photo comparisons of authentic vs counterfeit Prolene product.


[UPDATED December 19, 2003 and May 7, 2004 Public Health Web Notification - FDA]
[November 3, 2003 Letter - Ethicon]

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



CYPHER Sirolimus-Eluting Coronary Stent

Audience: Cardiology healthcare professionals
(October 29, 2003) FDA issued a FDA Public Health Web Notification to inform healthcare professionals of sub-acute thromboses (SAT) and hypersensitivity reactions with use of the Cordis CYPHER Coronary Stent. As of October 20, 2003, FDA has received more than 290 reports (>260 US and >25 outside US) involving sub-acute thrombosis (SAT) associated with the CYPHER stent. More than 60 reports of SATs were associated with patient death and the remaining reports were associated with patient injury requiring medical or surgical intervention. FDA also received more than 50 reports, including some deaths, that Cordis considers possible hypersensitivity reactions. The symptoms reported include: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.

[UPDATE November 25, 2003 Public Health Web Notification - FDA]
[October 29, 2003 Public Health Web Notification - FDA]
[October 29, 2003 Talk Paper - FDA]

Previous MedWatch alerts:
[July 7, 2003 Letter - Cordis Corporation] Adobe Acrobat [pdf] file
[July 8, 2003 FDA News - FDA]

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


Public Health Advisory - Suicidality in Pediatric Patients Treated with Antidepressants for Major Depressive Disorder
Audience: Mental health professionals, pediatricians, and other healthcare professionals
The FDA notified healthcare professionals of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). FDA has completed a preliminary review of such reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed. FDA plans to hold an advisory committee meeting before the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee on February 2, 2004.

[October 27, 2003 Public Health Advisory - FDA]
[October 27, 2003 Talk Paper - FDA]

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


Misys Healthcare Systems laboratory information system software
Audience: Clinical laboratory administrator and risk managers
December 18, 2003: The FDA Center for Devices and Radiological Health posted a Class I recall notice for Misys Healthcare Systems laboratory information system software, used to manage patient specimens in the laboratory for the diagnosis and treatment of a patient. Version 5.3 of the software has demonstrated a defect that could result when the information system uses 3 specific functions together, i.e. Rapid Order, Calculations, and Autofiling. Use of the defective laboratory information system software could result in the release of laboratory test reports without quality assurance validation and without abnormal results flags for critical values and abnormal results.

October 22, 2003 (NOTE: The following paragraph is outdated and incorrect, and has been replaced by the notice above) The FDA Center for Devices and Radiological Health posted a Class I recall notice for Misys Healthcare Systems laboratory information system software, used to manage patient specimens in the laboratory for the diagnosis and treatment of a patient. Versions 5.2, 5.23, and 5.3 of the software have demonstrated a defect that could result in quality assurance information not being included in the patient report. Use of the defective laboratory information system software could allow the release of potentially life-threatening results directly to patients without quality assurance validation.

[Corrected December 18, 2003 Recall Notice - FDA]

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


Valcyte (valganciclovir HCl tablets)
Audience: Transplantation and other healthcare professionals
FDA and Roche notified healthcare professionals of the findings of an active comparator study of Valcyte and ganciclovir in heart, liver, kidney, and kidney-pancreas transplant patients at high risk for CMV disease. Based on those findings: (1) Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk, (2) Valcyte is not indicated for use in liver transplant patients, and (3) The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients, such as lung transplant patients, have not been established.

[September 30, 2003 Letter - Roche]
[September 2003 Revised label - Roche] Adobe Acrobat [pdf] file PDF Format

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


Viread (tenofovir disoproxil fumarate)
Audience: Infectious Disease and other healthcare professionals
Gilead Sciences, Inc. notified healthcare professionals of a high rate of early virologic failure and emergence of nucleoside reverse transcriptase inhibitor (NRTI) resistance associated mutations observed in a clinical study of HIV-infected treatment-naïve patients receiving a once-daily triple NRTI regimen containing didanosine enteric coated beadlets (Videx EC, Bristol-Myers Squibb), lamivudine (Epivir, GlaxoSmithKline), and tenofovir disoproxil fumarate (Viread, Gilead). Based on these results, Tenofovir DF in combination with didanosine and lamivudine is not recommended when considering a new treatment regimen for therapy-naïve or experienced patients with HIV infection. Patients currently on this regimen should be considered for treatment modification.

[October 14, 2003 Letter - Gilead Sciences] Adobe Acrobat [pdf] file PDF Format

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


Lariam (mefloquine hydrochloride)
Audience: Pharmacists, infectious disease specialists and consumers
FDA and Roche Laboratories notified healthcare professionals of the introduction of the Lariam Medication Guide (MedGuide). The Lariam MedGuide was developed in collaboration with the FDA to help travelers better understand the risks of malaria, the risks and benefits associated with taking Lariam to prevent malaria, and the rare but potentially serious psychiatric adverse events associated with use of the drug. As required by law, a Lariam Medication Guide is supplied to patients each time Lariam is dispensed. Patients should be instructed to read the MedGuide when Lariam is received.

[September, 2003 Dear Healthcare Professional Letter - Roche] Adobe Acrobat [pdf] file PDF Format
[September, 2003 Dear Pharmacist Letter - Roche] Adobe Acrobat [pdf] file PDF Format
[September 30, 2003 Lariam Medication Guide - Roche Laboratories] Adobe Acrobat [pdf] file PDF Format
[August, 2003 Full, revised label - Roche] Adobe Acrobat [pdf] file PDF Format
[July 9, 2003 Press Release - FDA]

Previous MedWatch alerts:
[September, 2002 Letter to Physicians - Roche] PDF Adobe Acrobat [pdf] file or HTML format
[September, 2002 Letter to Pharmacists - Roche] PDF Adobe Acrobat [pdf] file or HTML format

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


CoaguChek PT test strips
Audience: Primary Care providers and consumers
The FDA Center for Devices and Radiological Health posted a Class I recall notice for CoaguChek PT test strips, used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, and to diagnose some disease conditions. Some of the foil pouches in which the test strips are packaged were improperly sealed allowing moisture and air to enter the pouch. These products give false results when exposed to moisture for more than a few minutes.

[October 8, 2003 Recall Notice - FDA]
[September 30, 2003 Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) - FDA]
[September 30, 2003 Product Recall Update for Health Professionals - Roche Diagnostics] Adobe Acrobat [pdf] file PDF Format
[September 30, 2003 Product Recall Update for Patients - Roche Diagnostics] Adobe Acrobat [pdf] file PDF Format


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


Keppra (levetiracetam) Tablets and Oral Solution
Audience: Pharmacists, Neurologists, and other healthcare professionals
FDA and UCB Pharma advised healthcare professionals of the risk of dispensing errors between KEPPRA (levetiracetam), an antiepileptic, and KALETRA (lopinavir/ritonavir), an antiretroviral. Patients with epilepsy who do not receive their antiepileptic drug due to a dispensing error would be inadequately treated and could experience serious consequences, including status epilepticus.

[September, 2003 Letter - UCB Pharma] Adobe Acrobat [pdf] file PDF Format

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


Roxanol (morphine sulfate) Concentrated Oral Solution
Audience: Pharmacists and other healthcare professionals
NOTE: A corrected "Dear Healthcare Professional" letter was issued October 22, 2003.

Elan Pharmaceuticals issued a "Dear Healthcare Professional" October 6, 2003 reporting serious adverse events and deaths resulting from accidental overdose of high concentration morphine sulfate oral solutions. In most of these cases, morphine oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product, resulting in 20-fold overdoses. Procedures for proper ordering and dispensing were included in the "Dear Healthcare Professional" letter.

UPDATE
[October 22, 2003 Corrected Letter - Elan Pharmaceuticals] Adobe Acrobat [pdf] file PDF Format

[June 13, 2003 Letter - Elan Pharmaceuticals]

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


FD&C Blue No. 1 (Blue 1) in enteral feeding solutions
Audience: Critical care specialists and other healthcare professionals
FDA alerted healthcare professionals of several reports of toxicity, including death, associated with the use of FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. In these reports, Blue 1 was intended to help in the detection and/or monitoring of pulmonary aspiration in patients being fed by an enteral feeding tube. Reported episodes were manifested by blue discoloration of the skin, urine, feces, or serum and some were associated with serious complications such as refractory hypotension, metabolic acidosis and death. Case reports indicate that seriously ill patients, particularly those with a likely increase in gut permeability (e.g., patients with sepsis), may be at greater risk for these complications.

[Sept 29, 2003 Public Health Advisory - FDA]

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


VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use
Audience: Clinical Microbiologists, Hospital Laboratory Staff and Risk Managers
The FDA Center for Devices and Radiological Health posted a Class I recall notice for this in-vitro diagnostic product, used in the laboratory on specimens collected from either symptomatic or asymptomatic patients for the qualitative detection of Chlamydia infections. The recalling firm is bioMerieux, Durham, N.C. A raw material, bovine serum albumin, contained in the VIDAS (CHL) reagent strip, is causing an accelerated degradation of the product’s performance and creating the potential for false negative results to be reported. Continued use of the defective assay could result in a moderate to high risk of serious adverse health consequences or death.

[Sept 26, 2003 Recall Notice - FDA]

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


Prandin (repaglinide)
Audience: Endocrinologists, pharmacists and other healthcare providers
Novo Nordisk and FDA revised the PRECAUTIONS/Drug Interaction section of the prescribing information to inform healthcare professionals of a drug-drug interaction between repaglinide (PRANDIN), a short-acting insulin secretagogue, and gemfibrozil (Lopid) a lipid-lowering agent used to treat dyslipidemia.

A study that evaluated the co-administration of gemfibrozil with PRANDIN in healthy subjects found a significant increase in repaglinide blood levels. Concomitant use may result in enhanced and prolonged blood glucose-lowering effects of repaglinide. For patients already on PRANDIN and gemfibrozil, blood glucose levels should be monitored and PRANDIN dose adjustment may be needed.

[Sept, 2003 Letter - Novo Nordisk] Adobe Acrobat [pdf] file PDF Format
[August, 2003 Revised, highlighted label - Novo Nordisk] Adobe Acrobat [pdf] file PDF Format

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


Orlaam (levomethadyl acetate hydrochloride)
Audience: Pharmacists and drug dependency healthcare professionals
Roxane Laboratories, Inc. is discontinuing the sale and distribution of ORLAAM, a synthetic opioid agonist solution indicated for the management of opiate dependence, reserved as second-line therapy for the treatment of opiate-addicted patients who fail to show acceptable response to other adequate treatments for opiate addiction. ORLAAM was removed from the European market in March 2001 following reports of severe cardiac-related adverse events, including QT interval prolongation, Torsades de Pointes and cardiac arrest. Other first-line treatment options are available for the management of opiate dependence, including methadone and buprenorphine. Roxane extimates that the current inventory of this product will be depleted by February 2004 and encouraged healthcare providers to transfer patients to alternative treatments as soon as possible prior to the product’s unavailability.

[Sept 2, 2003 Letter - Roxane Laboratories, Inc]

Previous MedWatch alerts:
[April 19, 2001 Letter - Roxane Laboratories, Inc] Adobe Acrobat [pdf] file PDF Format
[April 20, 2001 Talk Paper - FDA]

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


ProbeTec ET Instrument
Audience: Clinical Microbiologists, Hospital Laboratory Staff and Risk Managers
The FDA Center for Devices and Radiological Health posted a Class I recall notice for the ProbeTec ET Instrument, an in-vitro diagnostic medical device used for the detection of Chlamydia and gonorrhea in symptomatic and asymptomatic patients. The recalling firm is Becton Dickinson of Sparks, Maryland. A component of the in-vitro diagnostic device was incorrectly installed causing false positive and false negative results. Continued use of the defective instrument could result in a moderate to high risk of serious adverse health consequences, including death.

[August 21, 2003 CDRH Recalls Page - FDA]

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


Reyataz (atazanavir sulfate)
Audience: Infectious Disease and other healthcare professionals
BMS and FDA notified clinicians caring for HIV-infected patients of important new safety data concerning the coadministration of Reyataz (atazanavir sulfate) and Viread (tenofovir disoproxil fumarate.) Clinicians should use caution when administering unboosted Reyataz with tenofovir DF. Unboosted Reyataz may be less effective due to decreased atazanavir concentrations in patients taking Reyataz and tenofovir DF. As a result the coadministration of unboosted Reyataz with tenofovir DF may lead to loss or lack of virologic response and possible resistance to Reyataz.

[August 8, 2003 Letter - BMS]

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


Zenapax (daclizumab)

Audience: Transplantation healthcare professionals
FDA and Roche revised the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and CLINICAL STUDIES sections of the prescribing information to include important new safety information describing the increased mortality seen in a cardiac transplant study and other updated information regarding hypersensitivity reactions. Other sections of the ZENAPAX labeling impacted by the addition of the information from the cardiac transplant study have also been revised.

[August 2003 Letter - Roche]
[July 2003 Revised, highlighted label - Roche] Adobe Acrobat [pdf] file

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



Serevent Inhalation Aerosol (salmeterol xinafoate)
Serevent Diskus (salmeterol xinafoate inhalation powder)
Advair Diskus (fluticasone propionate and salmeterol inhalation powder)

Audience: Pulmonary specialists and other healthcare professionals
The FDA announced the addition of new safety information and warnings to the labeling for drug products that contain salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD). The new labeling includes a boxed warning about a small, but significant, increased risk of life-threatening asthma episodes or asthma-related deaths observed in patients taking salmeterol in a recently completed large U.S. safety study.

[August 2003 Letter - GlaxoSmithKline]
[August 14, 2003 Talk Paper - FDA]
[August 2003 Revised label, Serevent - GlaxoSmithKline] Adobe Acrobat [pdf] file
[August 2003 Revised label, Serevent Diskus - GlaxoSmithKline] Adobe Acrobat [pdf] file
[August 2003 Revised label, Advair Diskus - GlaxoSmithKline] Adobe Acrobat [pdf] file

Previous MedWatch alerts

[January 23, 2003 MedWatch Safety Alert]

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



Pyrazinamide plus Rifampin for Treatment of Latent Tuberculosis Infection (LTBI)
Audience: Infectious Disease and other healthcare professionals
The Centers for Disease Control and Prevention (CDC) notified healthcare professionals of revised recommendations against the use of rifampin plus pyrazinamide for treatment of latent tuberculosis infection, due to high rates of hospitalization and death from liver injury associated with the combined use of these drugs.

[August 8, 2003 Letter - CDC]
[August 8, 2003 MMWR Article - CDC]

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



Ziagen (abacavir)
Audience: Infectious Disease and other healthcare professionals
GlaxoSmithKline (GSK) notified healthcare professionals of a high rate of early virologic non-response observed in a GSK-sponsored clinical study of therapy-naive adults with HIV infection receiving once-daily three-drug combination therapy with lamivudine (Epivir, GSK), abacavir (Ziagen, GSK) and tenofovir (Viread, TDF, Gilead Sciences). Based on these results: Abacavir and lamivudine in combination with tenofovir should not be used as a triple antiretroviral therapy when considering a new treatment regimen for naive or pre-treated patients.

[July, 2003 Letter - GlaxoSmithKline] PDF Format Adobe Acrobat [pdf] file

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



Genotropin (somatropin [rDNA origin] for injection)
Audience: Pediatricians, endocrinologists and other healthcare professionals
Pharmacia and FDA revised the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Genotropin, indicated for the long-term treatment of pediatric patients who have growth failure. Fatalities have been reported with the use of growth hormone in pediatric patients with Prader-Willi syndrome with one or more of the following risk factors: severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection. Male patients with these factors may be at increased risk.

[May 30, 2003 Letter - Pharmacia]
[April 2003 Full, revised label - Pharmacia] Adobe Acrobat [pdf] file

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



Nortrel 7/7/7 - 28 Day Oral Contraceptive (norethindrone and ethinyl estradiol tablets, USP)

Audience: Pharmacists, reproductive health professionals, and consumers
Barr Laboratories announced a voluntary recall of 3 lots of its Nortrel 7/7/7 – 28 day (norethindrone and ethinyl estradiol tablets, USP) oral contraceptive product. The recall involves Lot Numbers 290122001, 290122002 and 290122003 and is being implemented because two individuals notified the company that the color-coded tablets in their product blister cards were in an improper sequence. Any woman who has received a Nortrel 7/7/7 – 28 day blister card with tablets in the wrong sequence could be at an increased risk of pregnancy. In addition, changes to the menstrual cycle, including delayed bleeding, irregular bleeding or spotting, may occur.

[July 9, 2003 Press Release - Barr Laboratories] PDF Format Adobe Acrobat [pdf] file

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



Topamax (topiramate) Tablets/Sprinkle Capsules

Audience: Neurologists, Pediatricians, and other Healthcare professionals
Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS sections of the prescribing information to provide updated information about oligohidrosis (decreased sweating) and hyperthermia, which have been reported in topiramate-treated patients. Oligohidrosis and hyperthermia may have potentially serious sequelae, which may be preventable by prompt recognition of symptoms and appropriate treatment.

[July 9, 2003 Letter - Ortho-McNeil] PDF Format Adobe Acrobat [pdf] file
[June, 2003 Revised label - Ortho-McNeil] PDF Format Adobe Acrobat [pdf] file

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



CYPHER Sirolimus-Eluting Coronary Stent

Audience: Cardiologists
Cordis Corporation issued a letter to inform healthcare professionals of a rare but potential risk of thrombosis associated with the use of the CYPHER Sirolimus-Eluting Coronary Stent. The letter provides clarification on the safe use of the product in accordance with the scientific evidence that led to product approval.

The CYPHER stent was approved in April 2003 for patients undergoing angioplasty procedures. Since the product’s introduction it is estimated that over 50,000 patients have received a CYPHER stent. To date, FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.

[July 7, 2003 Letter - Cordis Corporation] Adobe Acrobat [pdf] file
[July 8, 2003 FDA News - FDA]

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



Esprit Ventilator Model V1000

Audience: Hospital Risk Managers, respiratory care professionals
The FDA Center for Devices and Radiological Health posted a Class I recall notice for the Esprit Ventilator Model V1000 by Respironics California, Inc., of Carlsbad, California. Material used to construct three check-valves in this ventilator predisposed the valves to premature failure. There have been two patient injuries resulting in partial or complete failure to permit ventilation.

[July 2, 2003 Device Recall - FDA]

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


Health Nutrition (RMA Labs) Viga or Viga for Women Tablets
Audience: Healthcare professionals and consumers
Health Nutrition (RMA Labs) warned consumers not to purchase or consume the products known as Viga or Viga for Women Tablets. These products, which are being marketed as dietary supplements, contain the unlabeled drug ingredient sildenafil, which may pose possible serious health risks to some users. Viga is sold in bottles of 30 tablets, and in packet of 4 tablets (ten packets in one small box). VIGA for women is sold in bottle of 20 tablets. Both products are distributed by Health Nutrition (RMA Laboratories Inc) and sold without medical prescription.

The interaction between nitrates and sildenafil can result in profound and life-threatening lowering of blood pressure. The use of nitrates in any form is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate users is real, since erectile dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers and patients with ischemic heart disease.

[June 24, 2003 Press Release - Health Nutrition (RMA Labs)]

Previous related MedWatch alerts

Best Life Viga Tablets (Posted 5/29/2003)
Vinarol Tablets (Posted 4/9/2003)

Previous related FDA Alerts

FDA Warns Consumers Against Taking Some NVE, Inc. Supplements (June 20, 2003)

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

 

Lipitor (atorvastatin)
Audience: Pharmacists and consumers
(May 23, 2003) FDA announced that Albers Medical Distributors, Inc voluntary recalled 3 lots of 10 mg 90-count bottles of the cholesterol-lowering drug Lipitor and is warning healthcare providers and others that these three lots of counterfeit Lipitor represent a potentially significant risk to consumers. FDA's investigation into this matter is continuing.

(June 9, 2003) Albers expanded their original voluntary recall to include all lots of Lipitor that Albers purchased, which were packaged by Med-Pro.

[UPDATE June 9, 2003 - Press Release - Albers Medical Distributors, Inc.] PDF Format Adobe Acrobat [pdf] file
[UPDATE June 3, 2003 - Talk Paper - FDA]

[May 23, 2003 Talk Paper - FDA]
[May 22, 2003 Press Release - Albers Medical Distributors, Inc.]

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

 


Viga Tablets
(Best Life International)
Audience: Healthcare professionals and consumers
Best Life International warned consumers not to purchase or consume the product known as Viga. This product, which is being marketed as a dietary supplement, contains the unlabeled drug ingredient sildenafil, which may pose possible serious health risks to some users. Viga is sold in bottles of 30 tablets which are distributed by Best Life International Inc. This product is being promoted for increasing desire, confidence and sexual performance. The product is sold without medical prescription.

The interaction between nitrates and sildenafil can result in profound and life-threatening lowering of blood pressure. The use of nitrates in any form is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate users is real, since erectile dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers and patients with ischemic heart disease.

[May 23, 2003 Press Release - Best Life International]

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

 


Risperdal (risperidone)

Audience: Neuropsychiatric healthcare professionals
Janssen Pharmaceutica and FDA revised the WARNINGS section of the prescribing information for Risperdal (risperidone), indicated for the treatment of schizophrenia. Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis.

[April 16, 2003 Letter - Janssen Pharmaceutica]
[March, 2003 Full, revised label - highlighted changes - Janssen Pharmaceutica] Adobe Acrobat [pdf] file

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

 


INTERGEL Adhesion Prevention Solution

Audience: Gynecological healthcare professionals
GYNECARE Worldwide (a Johnson & Johnson Company) and FDA Center for Devices and Radiological Health (CDRH) announced the voluntary market withdrawal of “GYNECARE INTERGEL Adhesion Prevention Solution” from the global market and are urging customers to immediately stop using this device. Post-market reports include late-onset post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients a residual material was observed during the repeat surgery.

This product has been distributed in the following countries; Austria, Canada, Egypt, England, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Republic of Singapore, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and the United States.

[April 16, 2003 Statement - FDA / CDRH]

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

 


Vinarol Tablets

Audience: Healthcare professionals and consumers
Ultra Health Laboratories, Inc. and Bionate International, Inc. warned consumers not to purchase or consume a product known as Vinarol tablets, promoted for increasing desire, confidence and sexual performance. This product, marketed as a dietary supplement and sold over the counter as well as via the Internet, contains the unlabeled prescription drug ingredient, sildenafil, which may pose possible serious health risks to some users.

The interaction between nitrates and sildenafil can result in profound and life-threatening lowering of blood pressure. The use of nitrates in any form is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate users is real, since erectile dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers and patients with ischemic heart disease.

[April 4, 2003 Press Release - Ultra Health Laboratories, Inc.]

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

 


Lindane (gamma-hexachlorocyclohexane)

Audience: Primary Care providers, Pharmacists, and consumers
FDA issued a Public Health Advisory concerning the use of topical formulations of Lindane Lotion and Lindane Shampoo for the treatment of scabies and lice. A boxed warning emphasizes that it is a second-line treatment, updates information about its potential risks, especially in children and adults weighing less than 110 pounds, and reminds practitioners that reapplication of Lindane Lotion or Lindane Shampoo is not the appropriate treatment, if itching continues after the single treatment.

A Medication Guide, designed to inform patients of the risks of Lindane products and provide instructions for appropriate use of the drugs, must now be dispensed by the pharmacist with each new prescription.

[March 28, 2003 Public Health Advisory - FDA]
[March 2003 Label - Lindane Shampoo] Adobe Acrobat [pdf] file
[March 2003 Label - Lindane Lotion] Adobe Acrobat [pdf] file
[March 2003 Medication Guide - Lindane Shampoo]
[March 2003 Medication Guide - Lindane Lotion]

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



Procrit (epoetin alfa)

Audience: Pharmacists and Oncological healthcare professionals
FDA and Ortho Biotech Products alerted healthcare providers and consumers about the existence of three lots of counterfeit product labeled as Procrit (epoetin alfa):

P007645 - 40,000 units/mL, Expiration 10-2004
P004677 - 40,000 units/mL, Expiration 02-2004
P004839 - 40,000 units/mL, Expiration 02-2004

The counterfeit Procrit has been found to be contaminated with bacteria and therefore represents a significant potential hazard to consumers. FDA testing has demonstrated that some counterfeit product contains no active ingredient.

[March 11, 2003 Press Release - FDA]
[March 8, 2003 Letter - Ortho Biotech]

Past MedWatch alerts:

[June 6, 2002 Letter - Ortho Biotech] PDF Format Adobe Acrobat [pdf] file
[June 7, 2002 Update - Ortho Biotech] PDF Format Adobe Acrobat [pdf] file
[October 22, 2002 Update - Ortho Biotech]

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

 


Avonex (Interferon beta-1a)

Audience: Neurologists and other healthcare professionals
Biogen and FDA revised the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT INFORMATION, and CLINICAL STUDIES sections of the prescribing information to include important new safety information and a patient Medication Guide. Updated safety information includes a cautionary note regarding use in patients with depression and other severe psychiatric symptoms.

Post-marketing reports of depression, suicidal ideation and/or development of new or worsening of pre-existing psychiatric disorders, including psychosis, and reports of anaphylaxis, pancytopenia, thrombocytopenia, autoimmune disorders of multiple target organs, and hepatic injury manifesting itself as elevated serum enzyme levels and hepatitis were added to the labeling.

An FDA-approved Patient Medication Guide, providing important patient safety information and comprehensive instructions for patient self-administration of Avonex, was added.

[March 7, 2003 Letter - Biogen] PDF Format Adobe Acrobat [pdf] file
[February 2003 Full Revised Label - Biogen] PDF Format Adobe Acrobat [pdf] file
[February 2003 Medication Guide - Biogen] PDF Format Adobe Acrobat [pdf] file

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




Permax (pergolide mesylate)

Audience: Neurologists and other healthcare professionals
Lilly and FDA revised the WARNINGS section of the prescribing information to inform healthcare professionals of reports of cardiac valvulopathy involving one or more valves in patients receiving Permax therapy.

[February 2003 Letter - Lilly]

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



Rapamune (sirolimus)

Audience: Transplantation surgeons and other healthcare professionals
Wyeth, in cooperation with FDA, notified healthcare professionals of post-marketing reports of bronchial anastomotic dehiscence, including fatal cases, in lung transplant patients treated with Rapamune in combination with tacrolimus and corticosteroids. The safety and efficacy of Rapamune as immunosuppressive therapy has not been established in lung transplant patients.

[February 2003 Letter - Wyeth] PDF Format Adobe Acrobat [pdf] file

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



Serzone (nefazodone HCl)

Audience: Neuropsychiatric healthcare professionals and Pharmacists
Bristol-Myers Squibb notified healthcare professionals of medication errors due to name confusion between Serzone, indicated for the treatment of depression, and Seroquel, a product of AstraZeneca, indicated for the treatment of schizophrenia. The overlapping strengths (100 mg and 200 mg), the dosage form (tablets), the dosing interval (BID), and the fact that these two products are stocked close together in pharmacies were critical in causing these medication errors.

[December 9, 2002 Letter - Bristol-Myers Squibb] PDF Format Adobe Acrobat [pdf] file

Past MedWatch alerts:
[May 20, 2002 Letter - AstraZeneca] (Seroquel alert)

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



Serevent (salmeterol xinafoate)

Audience: Pulmonary specialists and other healthcare professionals
GlaxoSmithKline notified healthcare professionals of important new safety information on use of Serevent in patients with asthma. Recent findings from an interim analysis of a large Serevent safety study have prompted further review of the potential association between Serevent and rare, but potentially serious, respiratory adverse events.

[January 23, 2003 Letter - FDA] PDF Format Adobe Acrobat [pdf] file
[January 23, 2003 Talk Paper - FDA]

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



Ancom Anti-Hypertensive Compound Tablets

Audience: Pharmacists, other healthcare professionals, and consumers
(January 17, 2003) Herbsland Inc. recalled all 100 tablet bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a product with this combination of ingredients poses possible serious health risks including sedation, depression, and potentially life-threatening abnormalities of the blood. This recall includes all lot codes of the product remaining on the market. Ancom Tablets were sold without prescriptions to consumers through distributors and retail stores located in the New York City metropolitan area, specifically Manhattan, Brooklyn, and Queens. Nationwide sales are also possible as this product was sold via the Internet.

(UPDATE March 18, 2003) Ancom Tablets were sold without prescriptions to consumers at Tai Chien's retail establishment in New York City. Product was also sold to a distributor in Puerto Rico. At least one illness has been reported to date.

[March 18, 2003 Press Release - Tai Chien Inc.]
[January 17, 2003 Press Release - Herbsland, Inc.]

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



Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)
Premarin (conjugated estrogens tablets, USP)

Audience: Reproductive healthcare professionals
FDA and Wyeth revised the prescribing information to include a boxed warning, which states that estrogens and estrogens plus progestin therapies should not be used for the prevention of cardiovascular disease.

The boxed warning includes risk information from the Women's Health Initiative (WHI) study. The study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

[January 6,2003 Letter - Wyeth] PDF Format Adobe Acrobat [pdf] file
[January 2003 Prempro/Premphase Full Revised Label - Wyeth] Adobe Acrobat [pdf] file
[January 2003 Premarin Full Revised Label - Wyeth] Adobe Acrobat [pdf] file
[January 2003 Drug Information Page - FDA/CDER]

Past MedWatch Alerts:

[August 2002 MedWatch Safety Alert]

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