Raptiva Sales Suspension Urged in Europe after Reports of Deadly Brain Infections
February 20, 2009 — The European Medicines Agency (EMEA) has recommended that sales of Merck KGaA’s psoriasis drug Raptiva be suspended in Europe in light of serious brain infections confirmed in three Raptiva patients. According to the EMEA, a committee has concluded that “the benefits of Raptiva no longer outweigh its risks, because of safety concerns” following the three confirmed instances of progressive multifocal leukoencephalopathy, or PML. The European Commission will consider the EMEA’s advice and will likely suspend Raptiva sales, as it usually follows EMEA recommendations.
Raptiva, which has the generic name efalizumab, was approved in the United States in October 2003 and in Europe in September 2004 for treating moderate to severe plaque psoriasis, an autoimmune disease that causes scaly red patches on the skin. Approximately 46,000 patients have been treated with Raptiva worldwide. Because Raptiva works by suppressing the body’s immune system, it may leave patients vulnerable to infections, including PML.
In October 2008, Genentech, the company that markets Raptiva in the United States, added a “black box” warning to Raptiva after the first PML case was reported in a Raptiva patient. PML is a rare brain infection that leads to an irreversible decline in neurologic function and often causes severe disability or death. There is no known treatment for PML.
The U.S. Food and Drug Administration (FDA) is reviewing the three confirmed PML cases, as well as another possible case. Two of the Raptiva patients with confirmed PML and the Raptiva patient with suspected PML have died. All four patients were treated with Raptiva continuously for more than three years and ranged in age from 47 to 73 years old. None were receiving other treatments that suppress the immune system, the FDA said.
Raptiva PML Brain Infection Attorney
If you or a loved one has taken Raptiva and experienced serious side effects, such as PML or another type of infection, you may be entitled to compensation for your injuries.Contact our experienced Raptiva side effect attorneys today for a free and confidential case evaluation.