FDA Urges Caution For Users Of Novartis' MS Drug

Law360, New York (May 14, 2012, 4:52 PM EDT) -- The U.S. Food and Drug Administration said Monday that a safety review of Novartis AG's Gilenya found no solid evidence that the multiple sclerosis drug caused a patient's death last year, but that greater precautions are nonetheless needed for those using the treatment.

The FDA in December began investigating reports a Gilenya user in the U.S. died within 24 hours of the first dose, despite making it through the traditional six hours of monitoring without incident.

After analyzing the data, researchers found that while “a link...
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