FDA warns of cardiac risk with Gilenya
The FDA advised against use of the drug in patients with certain pre-existing cardiovascular conditions after a patient died within a day of taking a first dose.
The regulator could not definitively conclude that fingolimod was related to the death. However, based on re-evaluation of data, it remained concerned about bradycardia, which may occur as late as 20 hours after the first dose.
In Australia, fingolimod’s PI was updated on 27 April to include advice that all patients be monitored for six hours for signs of bradycardia. The FDA now calls for