UPDATE 1-U.S. calls for new warnings on Genentech skin drug

Thu Oct 16, 2008 4:18pm EDT
 
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WASHINGTON, Oct 16 (Reuters) - U.S. health regulators have ordered strong black-box warnings for Genentech Inc's DNA.N psoriasis drug, Raptiva, saying patients given the once-weekly injections are at risk for life-threatening infections.

The U.S. Food and Drug Administration said the new warnings, announced on Thursday, will alert doctors and patients to the risk of progressive multifocal leukoencephalopathy (PML) and other serious infections.

Raptiva, which is approved to treat moderate to severe forms of the scaly skin condition in adults, can also increase the risk of bacterial sepsis, viral meningitis and invasive fungal disease, the FDA said in a statement.

"Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks," Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said.

The agency called for the new warnings after receiving reports of Raptiva patients who were hospitalized, some of whom died, it said.

Genentech shares closed up 0.5 percent, or 43 cents, at $81.93 on the New York Stock Exchange. (Editing by Andre Grenon)

 
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