Psoriasis Drug Raptiva Linked to Rare Brain Infection

Susy Owen

Attorney

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The FDA is strongly recommending that doctors closely monitor their patients currently taking Raptiva while also monitoring those that have taken the medication in the past. According to reports from the FDA, it has received three confirmed cases and one possible case of a rare brain infection known as progressive multifocal leukoencephalopathy (PML). Two of the reported PML patients have died and one with possible PML has died. All of the patients had been taking the drug for three years.

Raptiva is used for the treatment of moderate to severe plaque psoriasis. The unfortunate side effect is that it also affects the T-cells of the immune system leaving patients susceptible to infections.

PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. Symptoms of the infection indicated by the FDA are weakness, blurred vision and difficulty speaking. 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.

In October, 2008, a black box warning (the most significant warning that can be given to a drug) was added addressing the risk of contracting certain life-threatening infections while taking Raptiva, including PML. While the European Union's equivalent of the FDA immediately recommended that the drug be withdrawn from the European market, the FDA continues to investigate whether the risks of the drug outweigh the benefits.