Reuters: Regulatory News: UPDATE 1-FDA says unsure if Novartis MS pill caused deaths

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UPDATE 1-FDA says unsure if Novartis MS pill caused deaths May 14th 2012, 15:30 Mon May 14, 2012 11:30am EDT May 14 (Reuters) - The U.S. Food and Drug Administration said it could not conclude that Novartis AG's multiple sclerosis pill Gilenya was related to unexplained deaths of patients, but it remains concerned about the cardiovascular effects of the drug after the first dose. In recent months, doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment. A committee of European Medicines Agency concluded last month that the benefits of the drug continue to outweigh its risks, but along with the FDA sought stronger warnings on heart risks.

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