FDA Issues Safety Alert for the Halting of Treatment with Fingolimod for Relapsing MS


The agency warned that halting treatment with fingolimod could lead to rare but possible worsening of the condition, as well as permanent disability.

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The FDA has issued a safety alert related to the halting of multiple sclerosis (MS) therapy with fingolimod (Gilenya, Novartis), stating that the condition can become much worse when treatment is stopped in comparison to while it was being taken or when it was first started.1

This worsening, the agency warned, is rare but may lead to permanent disability. Originally approved in 2010, fingolimod is used to treat relapsing MS. The agency recommended that health care professionals inform their patients before starting treatment about the potential risk of a severe increase in disability after stopping fingolimod.

Additionally, it suggested that health care professionals do the following:

  • Carefully observe patients for evidence of an exacerbation of their MS and treated appropriately when fingolimod is halted.
  • Advise patients to seek immediate medical attention if they experience new or worsened symptoms of MS after fingolimod is stopped.
  • Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.
  • Encourage patients to read the patient Medication Guide they receive with their fingolimod prescriptions, which explains the benefits and risks of the medicine.

For patients who have been instructed to stop fingolimod, the FDA suggested contacting their health professional immediately if you experience new or worsened symptoms such as weakness, trouble using arms or legs, and changes in thinking, eyesight, or balance. They advise against patients halting the medicine on their own, and suggested speaking to their health professional first, as stopping treatment can lead to worsening MS symptoms.

Healthcare professionals and patients are encouraged by the FDA to report adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. To do so, they can complete and submit the report online at www.fda.gov/MedWatch/report, by either downloading the form or calling 1-800-332-1088 to request a reporting form, and completing and returning to the address on the pre-addressed form. As well, it can be submitted by fax to 1-800-FDA-0178.

In September 2018, data were published showing that pediatric patients with MS who were treated with fingolimod had lower rates of relapse and less accumulation of MRI lesions over 2 years compared to interferon ß-1a. The adjusted annualized relapse rate was 0.12 with fingolimod compared to 0.67 (rate ratio, 0.18; 95% CI, 0.11 to 0.30; P <.001) for a relative difference of 82% and an absolute difference of 0.55 relapses (95% CI, 0.36 to 0.74; P <.001). Additionally, the annualized rate of new or newly enlarged lesions on T2-weighted MRI was 4.39 with fingolimod compared to 9.27 with interferon ß-1a (absolute difference, 4.88 lesions; relative difference, 53%; P <.001).2

In that study, the rate of serious adverse events (SAEs) was higher with fingolimod. In the fingolimod group, 16.8% (n = 18) of patients experienced ≥1 SAE, compared to 6.5% (n = 7) in the interferon group. In total, 5 patients (4.7%) and 3 patients (2.8%) in the fingolimod and interferon groups discontinued due to an AE, respectively. Although, 13 patients discontinued treatment in the interferon group due to an unsatisfactory treatment effect, compared to none with fingolimod. The overall incidence of AEs was 88.8% with fingolimod and 95.3% with interferon ß-1a.

“The overall safety profile in fingolimod was similar to adult studies,” study author Tanuja Chitnis, MD told NeurologyLive at the time. “Notable is an imbalance in seizures: 6 in fingolimod arm and 1 in the interferon-ß-1a arm. Other SAE’s occurred in 1 to 2 patients, without a consistent pattern. There was one case of second-degree heart block in a patient transitioning from the half dose to full dose of fingolimod, which resolved, and she continued on treatment.”

NeurologyLive has reached out to Novartis, fingolimod's manufacturer, for comment regarding the safety alert.


1. FDA. Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine. FDA website. Published November 20, 2018. fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm626264.htm. Accessed November 20, 2018.

2. Chitnis T, Arnold DA, Banwell BL, et al. Trial of fingolimod versus interferon beta-1a in pediatric multiple sclerosis. N Engl J Med. 2018;379:1017-1027.


: 10.1056/NEJMoa1800149.

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