Serious Side Effects of Raptiva - PML & Brain Infections

Progressive Multifocal Leukoencephalopathy (PML) has been reported in a post-marketing study. PML a serious bacterial, viral, fungal, and opportunistic infections have occurred, including pneumonia, sepsis, meningitis, and encephalitis. Some of these infections have been fatal. Postmarketing reports include cytomegaloviral infections; blastomyces, cryptococcal and tuberculous pneumonia; serious herpes infection; severe pneumonia with neutropenia (ANC 60/mm3); sepsis with seeding of distant sites; necrotizing fasciitis; and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment. Food and Drug Administration (FDA) has announced labeling changes, including a boxed warning, to highlight the risks of life-threatening infections with the use of Raptiva (efalizumab). FDA is also requiring the drug's manufacturer to submit a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Psoriasis is an inflammatory skin disease. Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy (treatment with light) to control their psoriasis.Raptiva was approved in 2003. It is manufactured by Genentech Inc. of San Francisco, Calif.