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On August 29, 2013, the FDA issued a drug safety alert after a European patient developed a rare and serious brain infectionprogressive multifocal leukoencephalopathy (PML)—after taking the drug Gilenya (fingolimod). Gilenya, which is manufactured by

Brain image

pharmacological giant Novartis, is used to treat relapsing forms of multiple sclerosis (MS) and has been reportedly prescribed to approximately 71,000 patients worldwide.

PML is caused by the John Cunningham virus, which damages the brain’s fatty covering (myelin). Myelin is critical for the proper functioning of the nerves in the white matter of the brain; therefore, PML usually causes death or severe disability.

This is not the first safety alert associated with Gilenya:

  • On December 20, 2011, the FDA reported on a patient with MS who died within 24 hours of taking the first dose of Gilenya.
  • On May 14, 2012, the FDA expressed concern over the cardiovascular effects of Gilenya.
  • In the September 5, 2012 issue of the Journal of the American Medical Association (JAMA), Thomas Moore and Curt Furberg, MD, PhD discussed seven major safety issues revealed through clinical trials of Gilenya:
    • Adverse effects on heart rate (including complete atrioventricular block)
    • Opportunistic infections
    • Reduced pulmonary function
    • Liver toxicity
    • Teratogenicity (the capability of causing birth defects)
    • Macular edema
    • Possible cancer risks

The FDA will continue to investigate the safety issues associated with Gilenya and will update the public accordingly.

If you or a loved one has been affected by Gilenya (fingolimod), contact us at or toll free at 1-800-644-1734.