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FDA recommends close cardiovascular monitoring after first dose of Gilenya

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One May 14, the U.S. Food and Drug Administration (FDA) recommended that patients starting on the multiple sclerosis drug Gilenya (fingolimod) be monitored for bradycardia for at least 6 hours after the first dose. The recommendation came after a review of additional clinical trial and postmarketing reports for Gilenya, including reports of patients dying of cardiovascular events or unknown causes. Although the FDA could not definitively conclude that Gilenya was related to any of the deaths, it “remains concerned about the cardiovascular effects of Gilenya after the first dose.” Although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose. Read more.

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