RAPTIVA, Psoriasis Drug, Causes Brain Infection Risks

April 8, 2009: Genentech and FDA announced a voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML).

PML is a brain disease that gets worse over time and can attack many parts of the brain at once. The brain infection is caused by a loss of white matter, a substance that protects nerve fibers in the brain. Without this white matter or myelin, nerve signals don't compute from the brain to the rest of the body. PML is caused by the reactivation of a common virus in the central nervous system of immune-compromised persons. The JC virus is carried by a majority of people and is considered harmless except for persons with lowered immune defenses. PML is most common among people with acquired immune deficiency syndrome (AIDS).

Symptoms vary but include clumsiness, gradual but progressive weakness, and a change in visual acuity, speech, and personality. These symptoms lead to a life threatening disability and can decline leading to death.

By June 8, 2009, Raptiva will no longer be available in the United States. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.

History
On February 19, 2009, the FDA announced that people who take Raptiva are at risk for developing the rare fatal condition known as PML. The FDA issued a public health advisory concerning three confirmed, and one possible report of PML, a rare brain infection, in patients using the psoriasis drug Raptiva. Three of those patients have died. All four patients were treated with Raptiva for more than three years. None of the patients were receiving other treatments that suppress the immune system.

On October 16, 2008, the FDA issued a black-boxed warning to highlight the risks of life-threatening infections from Raptiva, including PML.

The EMEA ("European Medicines Agency"), Europe's version of the FDA announced that the risks of Raptiva outweigh the benefits and should no longer be prescribed.

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