Possible Safety Issue Being Investigated with Novartis Pill Gilenya - National Multiple Sclerosis Society

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Possible Safety Issue Being Investigated with Novartis Pill Gilenya

December 12, 2011

Our sympathies go out to the family of an individual who recently died within 24 hours of receiving a first dose of the oral medication Gilenya® (fingolimod, Novartis). Novartis has confirmed this event and has reported it to the U.S. Food and Drug Administration. The FDA has issued a statement about this event.

Details of this unfortunate incident have not been released and are under investigation. Until more information is available about the circumstances of this individual’s death, it is impossible to know what role Gilenya may have played in it. According to company reports, more than 28,000 patients have received this new oral therapy to date. This event is being reported in various media outlets.

Individuals who have questions about Gilenya’s safety should contact the Novartis patient support line at 888-NOW-NOVA (888-669-6682) or the individual’s prescribing doctor.

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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