| FDA MedWatch | Recalls / Withdrawals | FDA Patient Safety News 1999 | 2000 | 2001 | 2002 | 2003 2003 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 
2002 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)
2001 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)
2000 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
1999 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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