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FDA Warns Users on Psoriasis Drug
Date:2/19/2009

ences at Texas A&M Health Science Center, said that people "who are on this medication currently should be made aware that it might cause brain infection [PML] or any other infections and possible symptoms so that they can contact their physician immediately."

People using the drug "need to be well-informed about the symptoms for PML infection and need to be monitored closely," he said.

Meanwhile, European regulators on Thursday called for sales of Raptiva to be suspended, Bloomberg news reported. In an e-mail cited by Bloomberg, the regulators said that "the benefits of Raptiva no longer outweigh its risks, because of safety concerns."

Raptiva, a once-weekly injection, suppresses the immune system to reduce psoriasis flare-ups, but this can increase the risk of serious infections and malignancies, experts noted. PML is caused by a virus.

Psoriasis is an autoimmune disease that usually shows up on the skin and can also manifest as psoriatic arthritis, according to the National Psoriasis Association.

Tysabri (natalizumab), a drug used to treat multiple sclerosis, also carries risk for PML, according to the FDA. And other biologics approved for psoriasis carry risks. Enbrel, for instance, will now carry a black-box warning noting the risk of serious infections.

In fact, a study reported last year found that almost one-quarter of biologic therapies approved in the United States and Europe since 1995 have been the subject of at least one safety-related regulatory action in the decade since they were approved. In October, the FDA mandated that Raptiva carry a black-box warning about the risk of life-threatening infections, including PML.

That announcement came on the heels of news from California-based drug maker Genentech, which makes Raptiva, that a 70-year-old patient taking the drug died after developing PML. At the time, it was the only confirmed case of PML in someone takin
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