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Pharmaceutical

FDA says 3 deaths associated with Genentech drug

February 25, 2009
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The Associated Press reports that three patients taking a Genentech drug are believed to have died of a rare brain infection, a known risk with the skin-clearing treatment, according to federal health officials. The Food and Drug Administration confirmed three cases and a possible fourth of progressive multifocal leukoencephalopathy, or PML, which causes swelling of the brain and is usually fatal. All the cases were reported in the last six months. The FDA announcement comes on the heels of the European Union regulators recommending a ban on marketing the drug. The European Medicines Agency stated "the benefits of Raptiva no longer outweigh its risks, because of safety concerns." The drug is marketed in Europe by Swiss drugmaker Merck Serono. The FDA said two U.S. patients who were diagnosed with the disease died, as did the additional patient who was believed to have the disease, but was never diagnosed. Genentech previously notified physicians and investors of the cases. First approved in 2003, Raptiva is a once-a-week injection used to treat red, scaly skin caused by psoriasis. The FDA in October added its most serious warning to Raptiva, after a 70-year-old patient caught PML and died after taking the drug for four years. The agency stressed in a statement posted to its Web site that patients should be aware of the symptoms of the infection, which include weakness, blurred vision and difficulty speaking. Doctors should likewise monitor patients taking the drug for these signs, the FDA said.

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