Tuesday, April 12, 2005

Once too slow, FDA approvals called too fast... April 10 Boston Globe story - "Over 15 years, the Food and Drug Administration has swung from taking too long to get medicine to dying AIDS patients to drawing fire for rushing drugs to market that wound up killing people. The agency's troubles were highlighted last week, when it asked Pfizer Inc. to suspend sales of Bextra because the painkiller can cause fatal heart and skin problems. Bextra was the latest casualty in a drug safety controversy that began last fall with Vioxx, an arthritis drug quickly approved by the FDA and then taken off the market..."  
  

FDA Calls for Warning on Antipsychotic Drugs Brief Reuters story at Yahoo - "The U.S. Food and Drug Administration on Monday ordered new warnings on antipsychotic drugs, alerting physicians to a higher death rate when the medicines are prescribed for atypical use of treating dementia in elderly patients. The black box warning affects Eli Lilly and Co.'s Zyprexa and Symbyax, AstraZeneca Pharmaceuticals LP's Seroquel, Johnson & Johnson's Risperdal, Novartis AG's Clozaril, Pfizer Inc.'s Geodon, and Bristol-Myers Squibb Co.'s and Otsuka America Pharmaceutical's Abilify. "