FDA Relays more Restictions for Gilenya


FDA Relays more Restictions for GilenyaOverview: The U.S. Food and Drug Administration (FDA) has added new restrictions to the Gilenya, placing extra precautions on high risk patients with cardiovascular history. The updated information is based on the completed evaluation of a reported patient death occurring within 24 hours last year.



  • FDA has added hourly pulse and blood pressure monitoring for all patients starting Gilenya
  • High risk patients are to be monitored longer than the initial six hours
  • Previously, the FDA contraindicated Gilenya in patients with a history of heart attack or stroke, and recommended EKG before and after the first dose for all patients

Product: Gilenya (fingolimod)

Manufacturer: Novartis

Side Effects & Complications

  • Bradycardia (slowed heart rate)
  • Dizziness
  • Fatigue
  • Palpitations

Drug Safety Communication

In its Drug Safety Communication issued yesterday, the FDA addressed serious safety concerns associated with Gilenya. In addition to reviewing reports of a patient who died within 24 hours of their first dose, the agency evaluated postmarket data and other Gilenya-related deaths. Although the FDA did not explicitly attribute Gilenya as the cause of death, the agency “remains concerned about the cardiovascular effects of Gilenya after the first dose”; Gilenya is known to cause bradycardia, or slowed heart rate.

The FDA noted that slowed heart rate usually occurs within the first six hours of starting Gilenya, but can also persist as late as 20 hours. The drug is already contraindicated in patients with a history of cardiovascular events such as heart attack, stroke, unstable angina and heart failure within the last six months, as well is in patients taking antiarrhytmic drugs. Additionally, all patients are to receive an electrocardiogram (EKG or ECG) before the first dose and after the standard six hour observation period, where cardiovascular health is monitored.

Now, US regulators are recommending that all patients who are starting Gilenya have their blood pressure and pulse taken on an hourly basis during the observation period. High-risk patients are to be monitored longer than six hours, with continuous EKG monitoring overnight. The FDA has classified the following conditions as high risk:

  • Patients who exhibit severe bradycardia after the first dose
  • Patients with any pre-existing conditions who cannot tolerate bradycardia
  • Patients taking drugs that slow down heart rate or atrioventricular conduction
  • Patients with an abnormal heart rhythm known as QT interval prolongation before or during the observation period
  • Patients taking drugs that prolong the QT interval, increasing the risk of a potentially deadly heart rhythm known as Torsades de pointes


The U.S. Food and Drug Administration (FDA) approved Novartis’ Gilenya in 2010 to treat multiple sclerosis. The drug raised concerns last December, following reports of a patient who died within 24 hours of the first dose; the report resulted in safety reviews and subsequent label changes by both US and European regulators, who later reported an additional 10 Gilenya-related deaths. Four of these patients died due to cardiac complications and the other six were unexplained.