Psychiatric Drugs Blasted Again!
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April 12, 2005 |
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Dementia Drugs Get Warning
By ANNA WILDE MATHEWS and
HEATHER WON TESORIERO The Food and Drug Administration, in the latest sign of its increasingly strong and public approach to major drug-safety concerns, called for tough cautions on the labels of seven antipsychotic medicines. The announcement endorsed a "black box" warning, the agency's strongest, about the risk of death in elderly dementia patients taking widely used drugs -- including Eli Lilly & Co.'s Zyprexa and Johnson & Johnson's Risperdal -- to control behavioral problems. Amid scrutiny from Congress on its handling of safety matters, the agency recently has taken several high-profile steps, including calling for strong label warnings for painkillers and asking for one, Pfizer Inc.'s Bextra, to be removed from the market. Yesterday's request focused on the new generation of drugs, known as "atypical" antipsychotics, largely used to treat psychiatric conditions such as schizophrenia. They aren't approved to treat behavioral disorders in dementia patients, but often are used "off label" for that. In addition to Zyprexa and Risperdal, the drugs affected were Lilly's Symbyax, AstraZeneca PLC's Seroquel, Novartis AG's Clozaril, Pfizer's Geodon, and Abilify, marketed by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. The FDA said its decision was based on a review of 17 clinical trials done with Zyprexa, Abilify, Risperdal or Seroquel in elderly dementia patients, that it felt indicated a likely risk for all similar drugs. Pulling the studies together, the agency said, it found that the risk of death was about 4.5% for patients taking the drugs, compared to 2.6% for those on placebo pills. The causes of death included heart problems and infections. Companies are examining the announcement. Eli Lilly said it already notes the death findings on labels of Zyprexa and Symbyax. J&J said the label for Risperdal includes a warning about strokes in dementia patients. Pfizer said it "will work with the agency to make sure the labeling meets the needs of patients and physicians." AstraZeneca is "still reviewing" the request and a Bristol-Myers Squibb spokesman said the company will "evaluate" the request. Novartis said it is committed to working with the FDA "to insure patient safety." Write to Anna Wilde Mathews at anna.mathews@wsj.com 1 and Heather Won Tesoriero at heather.tesoriero@wsj.com 2
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