Genentech's Raptiva receives new FDA warning

The Food and Drug Administration said Thursday it will update the labeling of Genentech Inc.'s psoriasis drug Raptiva to highlight the risk of several bacterial and viral conditions.

The added warnings follow Genentech's announcement earlier this month that Raptiva may have contributed to a patient getting progressive multifocal leukoencephalopathy, or PML, which causes swelling of the brain and is usually fatal. It is mostly seen in patients with immune deficiencies.

On Tuesday, Genentech said that a 70-year-old chronic plaque psoriasis patient died. He had been taking Raptiva for four years.

Psoriasis is a skin condition and autoimmune disorder.

The now-required Boxed Warning highlights the risk of bacterial sepsis, viral meningitis, invasive fungal disease, PML and other opportunistic infections. The label will also include data from juvenile animal studies in mice, which indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva juveniles.

The drug, which is a once-weekly injection, is not approved for children under 18 years of age.

Shares of Genentech finished the day up 43 cents to $81.93.