FDA Calls For Warning On Antipsychotic Drugs

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. The FDA said it is asking the companies to add the boxed warning to their labels describing the heightened risk and noting the drugs are not approved to treat symptoms of dementia in the elderly. The FDA said after reviewing 17 studies of four drugs in the class, the death rate for elderly patients on the medication were 1.6 to 1.7 times greater than those on a placebo. Most of the deaths were either heart related or from infections, the FDA said. Because the FDA believes it is a class effect, it is ordering the warnings on all drugs in the category, it said. More...