MS Drug Gilenya Under Review After 11 Deaths

Reports raise concern for a multiple sclerosis drug after 11 deaths were reported, all in which the patients had recently begun taking the drug. Novartis International AG, one of the largest multinational pharmaceutical companies based in Switzerland, came out with one of the first oral drugs used to help treat symptoms for multiple sclerosis. Gilenya, the oral medication, was approved in the U.S. and in Europe in 2010, but now, the drug is undergoing further safety testing.


Recent reports show the drug may have severe side effects on the heart, possibly leading to death. At this point, nothing has been confirmed but both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are reviewing the medication. According to an article in Business Week, concerns were sparked last November after a patient who had recently begun taking Gilenya died within 24 hours of starting his treatment. The article states, “ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to the disruption of heart rhythm, the London-based EMA said.” (read full article)

Novartis estimated around 30,000 patients are still being treated with Gilenya, Novartis and both agencies are notifying doctors about the possible side effects and have recommended all doctors to increase monitoring of patients’ hearts before beginning treatment and for at least six hours immediatly after beginning treatment. Though the drug has warning labels about the possibility of a slow heart rate and atrioventricular conduction block during your first treatment, it is still unclear whether or not the drug is the main cause of these deaths; the EMA and FDA hope to find out more information soon from continuous studies.


If you or a loved one have ever taken a prescription drug and felt you were not properly warned about the side effects or the drug did not work as you were told, don’t hesitate to contact an attorney. At Borchardt Law Firm we want to make sure the medicine patients are taking is safe. We have dealt with several defective prescription drug cases and feel the work we do will protect future generations of Texans. Feel free to give us a call.

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