WASHINGTON, Feb. 19 (UPI) -- The U.S. Food and Drug Administration issued a health advisory Thursday concerning serious events, including death, caused by the psoriasis drug Raptiva.
The federal agency said it has received three confirmed, and one possible, reports of progressive multifocal leukoencephalopathy -- a rare brain infection -- in patients using Raptiva (efalizumab). Three of the patients have died. All four patients were treated with the drug for more than three years and none was receiving other treatments that suppress the immune system.
The FDA said it is reviewing the information to ensure the risks of Raptiva don't outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML and that healthcare professionals carefully monitor patients for the possible development of the brain infection that is caused by a virus that affects the central nervous system.
Psoriasis is a chronic skin disease in which dry red patches covered with scales appears on the scalp, ears and genitalia.
Raptiva, manufactured by Genentech USA Inc., is a once-weekly injection approved for adults with moderate to severe plaque psoriasis.
