Safety Information

Therapeutic Biological Products

FDA MedWatch   |   Recalls / Withdrawals   |   FDA Patient Safety News

1999 | 2000 | 2001 | 2002 | 2003

For safety information after 2003, please see
MedWatch Safety Alerts for Drugs, Biologics, Devices, and Dietary Supplements http://www.fda.gov/medwatch/safety.htm


COUNTERFEIT PRODUCT ALERT - Counterfeiting of Procrit - Amgen, Inc / Ortho Biotech Products, LP - 3/8/2003 - Serious health risk to patients. Contaminants found. No active ingredient.

New Safety Alert - Interferon beta-1a (Avonex) - Biogen, Inc. - 3/7/2003


Risk of anaphylaxis based on worldwide post-marketing experience - Palivizumab (Synagis) - Medimmune, Inc - 11/27/2002

Important Prescribing Information - Urokinase (Abbokinase) - 10/22/2002

IMPORTANT DRUG WARNING - Counterfeiting of Procrit - Amgen, Inc / Ortho Biotech Products, LP - 10/16/2002 - (Updated 10/11/2002)

IMPORTANT DRUG WARNING - Counterfeiting of Epogen - Amgen, Inc - 5/8/2002 - (Updated 5/24/2002)


Remicade (Infliximab) - Centocor - Clinical Alert: Congestive Heart Failure
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. - MedWatch - 10/18/2001

Remicade (Infliximab) - Centocor -Black Box Warning 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. - MedWatch - 10/5/2001

Oprelvekin (Neumega) - Wyeth-Ayerst - 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. - MedWatch - 8/24/2001

IMPORTANT DRUG WARNING - Counterfeiting of Neupogen - Amgen, Inc. - 5/10/2001 (Updated 6/22/2001)


Etanercept (Enbrel), Immunex Corp., Post-marketing reports of adverse events of rare cases of nervous system disorders including demyelinating disorders such as multiple sclerosis, myelitis, and optic neuritis have been reported in patients with rheumatoid arthritis who have received Enbrel therapy - MedWatch - 10/10/2000

Trastuzumab (Herceptin), Genentech, Inc., Follow-up to May letter. Changes to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections - MedWatch - 10/6/2000

Basiliximab (Simulect), Novartis Pharmaceutical Corp., Postmarketing reports of seventeen cases of severe acute hypersensitivity reactions, including anaphylaxis, occurring in patients following the administration of Simulect. Other reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing. The onset of these reactions occurred within 24 hours following initial exposure and/or following re-exposure to Simulect - MedWatch - 10/6/2000

Interferon gamma-1b (Actimmune), InterMune Pharmaceuticals, Change in the expression of potency from units to International Units - MedWatch - 6/14/2000

Etanercept (Enbrel), Immunex Corp., Self administration difficulties - MedWatch - 5/12/2000

Trastuzumab (Herceptin), Genentech Inc., Postmarketing reports of serious adverse events - MedWatch - 5/3/2000

Recall of Dornase alfa, Pulmozyme, for packaging defect - MedWatch - 4/17/2000

Epoetin alfa (Epogen), Amgen Inc. - Problems with multiple use of labeled single use Epogen vials - MedWatch - 3/24/2000


Trastuzumab (Herceptin) - Reconstitution clarification - Medwatch - 9/23/1999

Serious Manufacturing Deficiencies with Abbokinase Prompt FDA Letter to Abbott Labs - 7/16/1999

Update on Abbokinase (Urokinase) - 3/22/1999

Warning Letter - Abbokinase (Urokinase) - 3/19/1999 - (PDF)

Letter to Abbott Laboratories Concerning Serious Manufacturing Deficiencies with Abbokinase - 7/14/1999

Etanercept (Enbrel), Immunex Corp. - Certain patients receiving Enbrel have developed serious infections, including sepsis, and several of these patients have died from their infections - 5/10/1999

New Warning For Arthritis Drug, Enbrel - HHS News - 5/12/1999

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