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FDA Issues Warning About Rare Worsening of MS After Stopping Treatment with Gilenya

November 21, 2018

  • The FDA has issued a safety announcement warning that in rare cases, MS can become much worse (compared to before or during treatment) after an individual stops treatment with Gilenya® (fingolimod), and this may result in permanent disability.
  • Individuals taking Gilenya are advised not to stop treatment without first talking to their MS healthcare providers.
  • Healthcare providers are advised to inform their patients of this information before initiating Gilenya, and to observe patients after treatment cessation for evidence of relapse so that it can be treated appropriately.
Details: The U.S. Food and Drug Administration has issued a safety announcement indicating that – in rare cases – when treatment with Gilenya (fingolimod, Novartis AG) is stopped, MS disease activity can become much worse than before the medicine was started or while it was being taken.
This warning is based on 35 cases of severely increased disability accompanied by the presence of multiple new lesions on MRI that occurred 2 to 24 weeks after Gilenya was stopped. Most experienced this worsening in the first 12 weeks. Of these cases, six eventually returned to the level of disability they had before or during treatment, but most experienced partial or no recovery.
The FDA advises that people should not stop taking Gilenya without first talking to their MS healthcare providers. As with other MS disease-modifying therapies, treatment with Gilenya may have to be stopped for various reasons, such as side effects/adverse reactions, pregnancy, or because the medicine is not working. Individuals should contact their healthcare providers immediately if they experience new or worsened symptoms of MS after treatment is stopped, including new or worsened weakness, decreases in mobility, or changes in cognitive function, vision, or balance.

The FDA advises healthcare providers to inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya, and to carefully observe patients who stop therapy for evidence of an MS relapse so that it can be treated appropriately.
Read the FDA warning
Read the patient medication guide for Gilenya
Read the full prescribing information

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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