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FDA Concludes Safety Review Of Novartis MS Drug Gilenya

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration Monday said Novartis AG's (NVS, NOVN.VX) multiple-sclerosis drug Gilenya shouldn't be used in patients with a recent history of stroke or some types of heart problems, concluding a safety review of the drug. The safety review was prompted by a report last November of a 59-year-old patient dying in the U.S. less than 24 hours after taking the first dose of the drug. The agency said it continues to recommend that doctors closely monitor the hearts of patients after they have been given the first dose of the drug because the product can lower a person's heart rate temporarily. As for the patient's death, the FDA said an exact cause of death couldn't be identified. The FDA said the patient had extensive brainstem MS lesions, which also have been associated with sudden death. The FDA also said it looked at other deaths that appeared to be from cardiovascular causes in patients who had been taking Gilenya and concluded that the drug's "contribution to the death was unclear." The FDA said the drug shouldn't be used in patients who have had a stroke or heart trouble within the past six months. The agency also said the drug shouldn't be used in patients taking some kinds of antiarrhythmic heart medicines. -By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

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