Tysabri Up for FDA Debate

February 2006

The Food and Drug Administration (FDA) faces a tough decision: Should the promising multiple sclerosis (MS) drug, Tysabri, be FDA approved again after being pulled from the market for potentially deadly side effects?

In 2004, Tysabri was withdrawn from the market by the FDA after its use was linked to a rare but fatal brain infection, progressive multifocal leukoencephalopathy (PMI). Since Tysabri shows such powerful effectiveness in treating MS, Biogen Idec Inc. and Elan Corp., makers of the drug, hope to convince the FDA to allow the drug to be put back on the market. Lotronex, a treatment for irritable bowel syndrome, is the only drug the FDA has allowed back on the market after a recall.

Previous studies have shown Tysabri reduced the rate of MS relapses by 66%. The drug also has a strong backing from MS patients who are willing to take the chance in order to ease their MS symptoms.

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