FDA approves labeling changes warning of risks associated with psoriasis treatment

WASHINGTON The Food and Drug Administration has approved labeling changes, including a boxed warning, concerning the risk of possibly fatal infections from the psoriasis drug Raptiva, the agency announced Thursday.

The drug, marketed by Genentech and known generically as efalizumab, is a once-weekly injection for adults with moderate to severe plaque psoriasis.

The boxed warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.