Raptiva may cause serious side effects

Patients taking the drug Raptiva, a treatment for moderate to severe psoriasis, may be at risk for developing progressive multifocal leukoencephalopathy (PML) a rare, but usually fatal virus that attacks the brain. Since October 2008, the U.S. Food and Drug Administration (FDA) has documented three deaths from PML. All three people were using Raptiva (generic name efalizumab), made by Genentech Inc., based in South San Francisco, Calif.

The National Psoriasis Foundation advises patients who are using Raptiva for psoriasis to work with their dermatologist to weigh the benefits of this drug against the risks. The Foundation also encourages patients who experience any symptoms of PML (unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes) to immediately seek medical attention.

While there have only been three documented cases out of 46,000 patients treated with Raptiva, the risk is clearly greater in patients treated for more than three years," according to Mark Lebwohl, M.D., professor and chairman of dermatology at the Mt. Sinai School of Medicine and chair of the National Psoriasis Foundation Medical Board. "Until now, Raptiva had one of the best safety profiles of drugs used to treat psoriasis."

The FDA approved Raptiva in 2003 to treat adults with moderate to severe plaque psoriasis through weekly injections. It is not approved to treat psoriasis in children less than 18 years of age.

Currently, the European Medicines Agency, Europe's drug monitoring agency, is recommending the suspension of Raptiva in Europe. No discussions of suspending the drug in the U.S. are under way.