FDA Alert: New Warnings on Fingolimod

The FDA has announced new warnings about potential cardiovascular effects of the multiple sclerosis (MS) drug fingolimod (Gilenya), following a review of clinical trial data prompted by the death of one patient after the first dose of the drug.

The agency noted that the death was not definitively tied to fingolimod, but that the drug causes a biphasic drop in heart rate, at about 6 hours and at 12 to 20 hours after the first dose. Fingolimod is now contraindicated for patients with certain heart conditions or events within the previous 6 months (including myocardial infarction, stroke, and transient ischemic attack) and in those who take Class Ia or Class III antiarrhythmic medications. The FDA also now recommends that cardiovascular monitor…