Regulators from both the U.S. and Europe are reviewing the multiple sclerosis (MS) drug Gilenya after 11 deaths have been linked to the pill’s use.
The European Medicines Agency (EMA) recently stated that the deaths raise concerns about the harm Gilenya may pose to the heart. Because of that, the agency initiated a review on the MS pill, Bloomberg reported.
The Food and Drug Administration has launched a similar review of Gilenya’s safety as well.
Gilenya’s drug manufacturer, Novartis, recently admitted that a patient passed away on November 23, 2011 after starting treatment with Gilenya. Ten other deaths have also been reported among patients who began to take the medication.
Gilenya was approved for use in the U.S. in 2010 and was cleared in Europe last March. It is the first oral treatment for the MS, which is a debilitating neurological disorder.
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