As we reported in October, pharmaceutical drug manufacturer, Genentech, was required by the Food and Drug Administration (FDA) to put a black boxed warning on the labeling for Raptiva regarding its association with dangerous and life-threatening infections like progressive multifocal leukoencephalopathy (“PML”). Today, Genentech voluntarily withdrew Raptiva, a psoriasis drug, from the market as a result of those risks.
PML is a very serious, rare, and progressive neurological disease that attacks multiple locations in the brain simultaneously, leading to visual problems, loss of coordination, other mental impairment, and eventually death. There is no cure for PML; and current treatments to boost the immune system can only slow the progression of the disease, not stop it.
Psoriasis is an autoimmune disease of varying severity thats presents with red scaly patches on the skin. Raptiva is an immunosuppressant drug, which actively weakens the immune system in order to combat the symptoms of psoriasis. In doing so, however, the patient becomes more susceptible to bacterial and other infections due to the immune system’s diminished state. Genentech, recently acquired by Roche Holding, said that although it had begun warning about the heightened risk of PML and other possible infections associated with Raptiva, it ultimately determined that the fatal risks outweighed the benefits of the drug.
There are approximately 2000 people currently taking Raptiva in order to manage the moderate to severe symptoms of psoriasis that they are experiencing. However, doctors have been told not to write any new prescriptions for the drug, and the drug will not be available at all after June 8, 2009.
If you or a loved one have been taking Raptiva for psoriasis, immediately talk to your doctor about discontinuing your use. If you have encountered any of the symptoms of PML described above or have suffered from any other infections while taking Raptiva, you should contact us immediately for a free consultation so that we can evaluate your case and make sure that your rights are protected.