March 1, 2009

Public Health Advisory Issued on Psoriasis Drug Raptiva

On February 19, 2009, the FDA issued a public health advisory for patients using the psoriasis drug Raptiva concerning three confirmed and one possible report of a rare but extremely serious brain infection called progressive multifocal leukoencephalopathy (PML) that has been linked to long-term use of the drug. Raptiva was approved by the FDA in 2003.The drug is administered weekly by injection to those suffering from moderate to severe plaque psoriasis. Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.  In the Fall of 2009, the drug received a “black box warning” for potential risk of developing life-threatening infections.  The FDA is continuing to monitor adverse events associated with Raptiva and strongly recommends that health care professionals carefully monitor patients using Raptiva (as well as those who have discontinued the drug) for any signs or symptoms of neurologic disease.



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