The manufacturer of the psoriasis treatment Raptiva (efalizumab) announced on April 8, 2009 that the drug would be withdrawn from the market due to a link with a potentially fatal brain infection. According to announcements of the Raptiva recall, at least four fatal cases of progressive multifocal leukoencephalopathy (PML) had been identified among patients who were treated with the psoriasis drug.
This recall notice came just two months after the Food and Drug Administration issued a public health advisory to warn doctors and patients about the link between Raptiva and PML. In October 2008, the FDA forced the manufacturers of the drug to add a “black-box” warning to its label about the increased risk of potentially deadly infections, including PML.
Raptiva is a once-a-week injection first sold by Genentech in 2003 for the treatment of chronic plaque psoriasis. More than 46,000 patients had been treated with this medication since it was first put on the market.
Psoriasis is a long-lasting disease which causes thick scales or itchy red patches to form on the surface of the skin. Because psoriasis is an autoimmune disorder—a condition in which the body’s immune system attacks itself—Raptiva works to treat the condition by affecting the body’s T-cells and decreasing the immune response.
But because of this decreased function of the immune system, patients taking Raptiva are at a higher risk of infections, and thus, at an increased risk of PML. Patients who develop PML often suffer a severe and irreversible decline in their neurological functions, which may lead to severe disabilities or death. There is currently no way of telling who might be at risk of PML, and no effective treatment for the disease.
After announcing a recall because of the risk of Raptiva side effects, Genentech said that the drug would only continue to be sold until June 8, 2009. According to the Food and Drug Administration, this was to give psoriasis patients enough time to meet with their doctors and decide on another way to treat their condition. Doctors were also advised by the FDA not to begin treating any new patients with Raptiva.
If you or a loved one have developed neurological problems after taking Raptiva—which may indicate a serious infection leading to PML—contact the law office of Hissey Kientz, LLP to learn more about your legal rights. You can contact us by calling our toll-free number at (866) 275-4454, or by filling out a free case evaluation form to the right of this page.