Psoriasis Drug Raptiva gets FDA Warning

The Food and Drug Administration is giving a "black box" warning to Raptiva, the psoriasis drug, about the risk of life-threatening infections including a rare brain infection and meningitis.

Genentech Inc.'s drug Raptiva will now have a Boxed Warning highlighting 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 warning follows Genentech's announcement that the drug Raptiva may have resulted in a 70 year old chronic plaque psoriasis patient taking Raptiva for four years getting progressive multifocal leukoencephalopathy, or PML, which causes swelling of the brain and dying.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a news release that the FDA ordered Raptiva's "black box" warning and other label changes after receiving reports of serious infections in some patients taking the drug. The FDA though is not stopping patients from taking Raptiva and acknowledges that one case of PML does not establish that the drug causes any illness. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to the risks," Woodcock says.

Raptiva is given by injection once a week and the drug is not approved for children under 18. The FDA recommends that patients taking Raptiva should be alert for signs of infection and seek immediate medical attention if they have any medical problems like confusion, dizziness, bleeding gums or numbness or weakness in arms and legs. Patients are also urged to get up to date on their vaccinations before starting the drug and not get vaccinated while on the drug as they may develop immunity to the vaccination virus.

Genentech spokeswoman Krysta Pellegrino said they will issue a letter to doctors and other health care providers detailing the label changes. "We feel it's important that patients and doctors are educated about the signs and symptoms of infections and the other information included in the boxed warning."