The FDA issued a warning yesterday confirming that another patient taking the psoriasis drug Raptiva developed a rare form of brain infection called progressive multifocal leukoencephalopathy (PML).

The warning came after Genentech reported that a 47 year old man in Germany had been hospitalized for the infection. Two other patients--a 70 year old and a 73 year old--died of PML in October and November of last year. All of the patients who developed PML were taking the psoriasis drug for more than three years. The drug already carries a black-box warning, the sternest warning required by the FDA.

In response, Tara Cooper, spokesperson for Genentech, said, "As a company, we take the risk of PML very seriously and we're working with the FDA to put the right plan in place to protect people's safety. We're looking at all possible approaches, including a risk minimization plan." Since its approval in 2003, more than 46,000 patients have taken Raptiva to combat moderate and severe chronic plaque psoriasis, she said.

PML occurs in people with weakened immune systems--organ transplant and AIDS patients, those with cancers like Hodgkin's disease, and those taking immunosuppressant drugs. It occurs when a normally harmless virus, called Polyomavirus JC, flares up and attacks the myelin in the brain.

Three patients developed PML while taking the multiple sclerosis drug Tysabri before it was pulled from the market in 2005. Since it was reintroduced in 2006 with more stringent restrictions and warnings, four more cases have been reported, the last in December, 2008.


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