Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Drugs

Drugs

                        


                        Regulatory Science Research and Education
          Development & Approval Process | Drugs
          Drug Safety and Availability
          Emergency Preparedness | Drugs
          Guidance, Compliance, & Regulatory Information
          News & Events for Human Drugs
          Resources | Drugs
          Science and Research | Drugs Home
          Drugs
          FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)Drugs FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
  
  	
    Share
    Post
    Linkedin

    Email
    PrintListen

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On November 20, 2018 FDA warned that when the multiple sclerosis (MS) medicine Gilenya (active ingredient fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability. As a result, we have added a new warning about this risk to the prescribing information of the Gilenya drug label and patient Medication Guide.

Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.

**Health care professionals** should inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya. When Gilenya is stopped, patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately. Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.

Since approval of Gilenya in September 2010, we identified 35 cases of severely increased disability accompanied by the presence of multiple new lesions on magnetic resonance imaging occurring 2 to 24 weeks after Gilenya was stopped. Most patients experienced worsening in the first 12 weeks after stopping. Our analyses include only reports submitted to FDA and those found in the medical literature, so there may be additional cases about which we are unaware. The increase in disability in these patients was more severe than typical MS relapses, and in cases where baseline disability was known, appeared unrelated to the patients’ prior disease state. Seventeen patients had partial recovery, eight permanent disability or no recovery, and six eventually returned to the level of disability they had before or during Gilenya treatment.

We communicated safety information about Gilenya in August 2015 and August 2013 on rare brain infections, May 2012 on revised cardiovascular monitoring recommendations, and December 2011 on a safety review of reported death.

Side effects involving Gilenya should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and 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.

And follow us on Twitter @FDA_Drug_Infofor up to the minute important drug information.

Thank you for listening.

Related Information

FDA Drug Safety Communication: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
	FDA Drug Safety Podcast: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)

                                                                                  Content current as of:
      01/19/2022Drugs

          
                        


                        Regulatory Science Research and Education
          Development & Approval Process | Drugs
          Drug Safety and Availability
          Emergency Preparedness | Drugs
          Guidance, Compliance, & Regulatory Information
          News & Events for Human Drugs
          Resources | Drugs
          Science and Research | Drugs
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop