SAFETY ALERT: FDA to Conduct Safety Review of Gilenya Following Death After First Dose

The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod; Novartis). At this time, FDA cannot conclude whether the drug resulted in the patient's death and continues to believe that Gilenya provides an important health benefit when used as directed. The FDA recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug labeling. According to the post-marketing report submitted to the FDA's Adverse Events Reporting System (AERS) database, the patient was also treated with metoprolol, a beta blocker, and amlodipine, a calcium channel blocker. The patient had completed six hours of monitoring after the first dose without incident, but died less than 24 hours after the first dose. The FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.

Gilenya is indicated for the treatment of relapsing forms of MS, to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm.