The Food and Drug Administration announced today that the label of Genentech Inc's psoriasis drug Raptiva will include a boxed warning to highlight the risk of life-threatening infections, such as bacterial sepsis, viral meningitis, invasive fungal disease and even progressive multifocal leukoencephalopathy (PML). PML is mostly seen in patients with immune deficiencies causing swelling of the brain. The condition is usually fatal.

Raptiva also known as efalizumab is a once-weekly injection prescribed for adults with moderate to severe plaque psoriasis. The drug works by suppressing the immune system to reduce psoriasis flare-ups, but, by suppressing the body’s natural defense system, it can also increase the risk of serious and malignancies in patients.

The decision follows reports to the FDA’s Office of Surveillance and Epidemiology of hospitalizations and deaths resulting from infections linked to the use of the drug.

“As part of FDA’s monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling,” Janet Woodcock, the FDA’s director of its Center for Drug Evaluation and Research, said.

She further added that doctors should be careful when prescribing Raptiva and weigh the risk and benefits of the drug in patients who would be more susceptible to the above-mentioned risks.

On the other hand, Genentech spokeswoman Krysta Pellegrino said the company was only aware of one case of PML which they reported earlier this month. It involved a 70-year-old patient who received Raptiva for more than four years. However, the company will add the new warning to the drug’s label and send doctors a letter notifying them of the change. 

Last month, another Genentech drug, Rituxan was labeled with a warning about a rheumatoid arthritis patient who died from PML.