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FDA Drug Safety Podcast for Healthcare Professionals: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya,active ingredient fingolimod

This update is in follow-up to the FDA Drug Safety Communication: Safety review of a reported death after the first dose of multiple sclerosis drug Gilenya on 12/20/2011.

LCDR Jennifer Shepherd, a US Public Health Service Pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On May 14, 2012, the FDA issued a Drug Safety Communication informing the public it has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya. The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.  FDA could not definitively conclude that Gilenya was related to any of the deaths. However, based on its reevaluation of the data, 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 6 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, Gilenya is now contraindicated in patients with certain pre-existing or recent heart conditions or stroke, or who are taking certain antiarrhythmic medications.

FDA continues to recommend that all patients starting Gilenya be monitored for signs of bradycardia for at least 6 hours after the first dose.  FDA is now recommending hourly pulse and blood pressure measurement for all patients starting Gilenya. 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, FDA is now also recommending that the time of cardiovascular monitoring be extended past 6 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:

  • Patients who develop severe bradycardia after administration of the first dose of Gilenya
  • Patients with certain pre-existing conditions in whom bradycardia may be poorly tolerated
  • Patients receiving other drugs that slow the heart rate or AV conduction, or  drugs that may prolong the QT interval and that can cause Torsades de pointes
  • Patients with QT interval prolongation prior to starting Gilenya, or at any time during the cardiovascular monitoring period

At this time FDA recommends that:

  • Healthcare professionals review the updated drug label for Gilenya and note specific FDA recommendations for monitoring patients and the new contraindications for use in certain patients.
  • And please continue to report adverse events involving Gilenya to the FDA MedWatch program at www.fda.gov/medwatch.

FDA will update the public if any additional information on the cardiovascular risks of Gilenya becomes available.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 


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