Multiple Sclerosis

FDA: Stopping MS Medication May Exacerbate Symptoms

Individuals who stop taking the multiple sclerosis (MS) medication fingolimod (Gilenya) may experience a severe increase in disability, with MS symptoms having the potential to become worse than before or while the medication was being taken, according to the US Food & Drug Administration (FDA).1

 

“This MS worsening is rare but can result in permanent disability,” the FDA wrote in a statement.

 

Since the FDA’s approval of fingolimod in 2010, the FDA has identified 35 patients who experienced worsened MS symptoms upon stopping the medication—usually within the first 12 weeks of discontinuation.2

 

As a patient is deciding whether to take fingolimod, health care professionals should make clear the potential risk of worsened MS symptoms after stopping the medication.

 

Once patients stop taking the medication, they should be carefully observed for any evidence of worsened MS symptoms.

 

If an increase in disability does occur, the FDA encourages health care professionals to test for new or enhancing lesions by magnetic resonance imaging.

 

—Colleen Murphy

 

References:

  1. Gilenya (fingolimod): drug safety communication - severe worsening of multiple sclerosis after stopping the medicine [press release]. Silver Spring, MD: US Food & Drug Administration; November 11, 2018. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm626264.htm. Accessed November 26, 2018.
  2. FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod) [press release]. Silver Spring, MD: US Food & Drug Administration; November 20, 2018. https://www.fda.gov/Drugs/DrugSafety/ucm626095.htm. Accessed November 26, 2018.