Gilenya (fingolimod) Drug Safety Communication

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Gilenya (fingolimod): Drug Safety Communication – Safety Review of a Reported Death After the First Dose

AUDIENCE: Neurology, Patients

ISSUE: 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). At this time, FDA cannot conclude whether the drug resulted in the patient’s death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.

BACKGROUND: Gilenya (fingolimod) is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Gilenya is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability. 

RECOMMENDATION: At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label.  Patients with MS should not stop taking Gilenya without talking to their healthcare professional.

FDA will communicate any new information on Gilenya and this case when it becomes available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm

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