The Genentech drug approved in October 2003 for the treatment of moderate-to-severe psoriasis in adults may be to blame for causing progressive multifocal leukoencephalopathy (PML), a rare and usually fatal viral disease of the brain. The FDA also is aware of a fourth possible PML case linked to Raptiva, but has not yet confirmed the connection, officials said.



The FDA is reportedly investigating Raptiva and will "take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits."

Raptiva is given by injection once a week for psoriasis in adults who are candidates for systemic (whole body) therapy or phototherapy (light) therapy to control the disease. Raptiva suppresses the immune system to reduce psoriasis flare-ups, but in doing so, can raise the risk of serious infections and malignancies, officials said.

More Trouble for Raptiva

Raptiva has been in the news for years and linked to several life-threatening side effects. In October 2008, the FDA ordered the drug's maker to include a Black Box Warning on the packaging to alert physicians and users of the increased risks of PML, meningitis, and other life-threatening infections. The FDA also required Genentech to develop a medication guide and other literature for the packaging.

In July 2005, the FDA ordered Genentech to strengthen the safety warnings for Raptiva to warn users about immune-mediated hemolytic anemia, which occurs when the immune system mistakes oxygen-carrying red blood cells for foreign substances and destroys them.

Europe Leans Toward Banning Raptiva

While Raptiva remains a treatment for psoriasis patients in the United States, health-safety regulators in Europe have already indicated that they are leaning toward pulling the drug from pharmacy shelves. The European Medicines Agency has said that sales of the drug should be suspended because of the link to cases of PML, saying that the benefits of Raptiva no longer outweigh the risks and safety concerns.

The agency recommended that Raptiva no longer be prescribed, but no formal action to ban Raptiva in Europe has followed that recent recommendation.

Other Drugs Linked to PML

Other drugs like Tysbari, a MS medication, have been linked to progressive multifocal leukoencephalopathy as well. In fact, the FDA took Tysabri off the market for a brief period of time because patients died from PML after using the drug. However, the FDA decided to let the drug back on the market because of the lack of treatment options for Mutiple Sclerosis.

However, Raptiva treats psoriasis, a disease that is not nearly as serious as multiple sclerosis. The FDA may need to consider if the side effects of the drug warrant the drug being on the market. Raptiva is not the only effective treatment for psoriasis.