FDA Revises Drug Safety Recommendations for Cardiovascular Monitoring and Use of Multiple Sclerosis Drug Gilenya (Fingolimod)

Gilenya (Fingolimod) is an oral medication for the treatment of relapsing forms of multiple sclerosis (MS) in adults. It is used to reduce the frequency of flare-ups (clinical exacerbations) and to delay the progression of the physical symptoms of MS.


The FDA completed its evaluation of a report of a patient who died after the first dose of this drug. The FDA also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. The FDA could not definitively conclude that Gilenya was related to any of the deaths. However, based on its reevaluation of the data, the FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within six hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients. 


For this reason, the FDA advises against its use. In other words, Gilenya is now contraindicated in patients with certain pre-existing or recent (within the last six months) heart conditions or stroke, or who are taking certain antiarrhythmic medications.


The FDA continues to recommend that all patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least six hours after the first dose. The FDA is now recommending hourly pulse and blood pressure measurement for all patients starting Gilenya. Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period. Cardiovascular monitoring should continue until any symptoms resolve.


In addition, the FDA is now also recommending that the time of cardiovascular monitoring be extended past six hours in patients who are at higher risk for or who may not tolerate bradycardia. Extended monitoring should include continuous ECG monitoring that continues overnight. These higher risk patients include those:


  • Who develop severe bradycardia after administration of the first dose of Gilenya
  • With certain pre-existing conditions in whom bradycardia may be poorly tolerated
  • Receiving therapy with other drugs that slow the heart rate or atrioventricular conduction
  • With QT interval prolongation (a type of heart rhythm abnormality) prior to starting Gilenya, or at any time during the cardiovascular monitoring period
  • Receiving therapy with other drugs that prolong the QT interval and that can cause a serious and life-threatening abnormal heart rhythm called Torsades de pointes


Healthcare professionals are encouraged to review the updated drug label for Gilenya and note specific FDA recommendations for monitoring patients and the new contraindications for use in certain patients.


Patients should not stop taking Gilenya without talking to their healthcare professional. They should contact their healthcare professional and seek immediate care if they develop dizziness, tiredness, irregular heartbeat, or palpitations--signs of a slowing heart rate. The FDA continues to believe that the benefits of treatment with Gilenya outweigh its potential risks when it is used as described in the updated drug label.


See the FDA Drug Safety Announcement