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FDA OKs Raptiva drug labeling changes

WASHINGTON, Oct. 16 (UPI) -- The U.S. Food and Drug Administration says it has approved labeling changes for the psoriasis drug Raptiva, including a warning about infection risks.

The FDA said the new labeling will include a boxed warning concerning the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

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Raptiva (efalizumab) is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy to control their psoriasis.

"As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva, These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of its Center for Drug Evaluation and Research.

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, the FDA said, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Raptiva is manufactured by Genentech Inc. of San Francisco.

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