FDA Extends Cardiovascular Monitoring for Gilenya
The FDA has revised its recommendations for cardiovascular monitoring after the initiation of Gilenya (fingolimod), Novartis’s oral drug for relapsing-remitting MS. The new recommendations, which extend the post-dosage monitoring for bradycardia from 6 to 24 hours, are based on the report of a woman who died within a day after starting the drug.
Although the cause of the woman’s death was not determined, the agency reported that she was taking two antihypertensive medications, including the beta-blocker metoprolol. In addition, she had “extensive” MS lesions in her brainstem, which have been associated with sudden death.
On the basis of a post-hoc analysis of clinical-trial data, the FDA also concluded that the possible depressant effect of Gilenya on the heart rate is biphasic: There is an initial risk during the first 6 hours after the first dose and a second risk during hours 12-20. Therefore the agency believes that cardiac monitoring beyond 6 hours is warranted in patients whose heart rate falls below 45 bpm during the first 6 hours after the first dose.
Other reports of cardiovascular death in Gilenya-treated patients are being examined. However, the FDA cautions, “For
each of these deaths, Gilenya’s contribution to the death was unclear.
The number of deaths of apparent cardiovascular origin or of unknown
origin does not appear to be higher than in MS patients not treated with
Regardless it seems prudent to consider the drug very carefully in MS patients with concomitant cardiovascular disease (especially arrhythmia) and particularly those patients taking beta-blockers or antiarrhythmics.