The Food and Drug Administration has reported that U.S. regulators have received three confirmed reports of a serious brain infection in patients treated with Genentech's psoriasis drug Raptiva.
The FDA said it also was aware of a fourth possible case of progressive multifocal leukoencephalopathy (PML) in a Raptiva patient. Two of the patients with confirmed PML died, as did the patient with a possible case, the agency said.
The FDA said it was reviewing the information and their investigation is on-going. On October 16, 2008 the FDA mandated a "black box" warning for Raptiva, the FDA's sternest warning, about the risk of life-threatening infections.
PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.
Raptiva is a weekly injection used to treat plaque psoriasis. Psoriasis is a disorder affecting joints and skin. It is a chronic condition and its cause is unknown. Psoriasis causes skin inflammation and scaly skin patches. Plaque psoriasis is the most common type of psoriasis, accounting for 80-90% of cases. Psoriasis can be mild to severe.
Raptiva is designed to treat severe psoriasis. It is used in adults who are in need of either phototherapy (light therapy) or other systemic (oral or injected therapy) treatments. Raptiva works by supressing the immune system to reduce psorasis flare ups but, as with many other immunosuppressive medications, the tendency for serious infection is much greater. Raptiva “suppress [es] the body’s natural defense system.” Without the body’s defense system, there is a serious risk patients using Raptiva will contract life-threatening infections. Published reports have also noted an increased tendancy for thrombocytopenia (low platelet counts) in Raptiva patients.
Dozens of Raptiva users have contacted Audet and Partners, LLP recently regarding Raptiva. If you or a loved one has taken Raptiva, and have suffered from progressive multifocal leukoencephalopathy (PML), please contact our law firm immediately to protect your legal rights.
