Raptiva, Drug to treat Psoriasis, Linked to Rare Brain Infection

The FDA reported late last week that the psoriasis drug Raptiva may be linked to a rare, often fatal, brain infection known as progressive multifocal leukoencephalopathy, or PML. According to the FDA, it has received reports of 3 confirmed cases and one possible case of PML in patients being treated with Raptiva for moderate to severe plaque psoriasis. Two of these patients who were confirmed with PML have died and the the one possible PML also died. All of the patients had been taking the drug continuously for 3 years. There is no known treatment for PML.
In October of last year 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. The FDA indicates it is reviewing this latest information to determine if the risks of this drug outweigh its benefits. At the same time, the European Union’s equivalent of the FDA, the European Medicines Agency (EMEA), has recommended that the drug be withdrawn from the European market. The EMEA has already determined that the risks of this drug outweigh its benefits. In Europe, the European Commission must approve the EMEA recommendations, but it typically does.
The FDA strongly recommends that doctors closely monitor their patients taking Raptiva, as well as those who have taken the drug in the past. Symptoms of the infection indicated by the FDA are weakness, blurred vision and difficulty speaking.
If you are presently taking this drug, or have in the past, you might want to consider contacting your treating physician and discussing this issue with him. I will say its curious that the EMEA immediately jumped on removing the drug from the market, while the FDA still needs to continue to look at this issue. There are other treatments on the market for psoriasis, so the delay by the FDA raises the issue again of the tail wagging the dog i.e. is Big Pharma again calling the shots.