Raptiva Psoriasis Drug PML Brain Infection Deaths

On February 19, 2009, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory concerning four reports of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients died and all four patients were treated with Raptiva for more than three years. None of the patients were receiving other treatments that suppress the immune system.

On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information regarding the risk of PML in patients using the medication. On October 2008, Raptiva's label was changed to highlight the risk of life-threatening infections, including PML. Around the same time, Genentech was told to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure patients received vital information about Raptiva.

Those steps, however, were not enough and on April 8, 2009, Raptiva was voluntarily withdrawn from the market.

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.

PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.