Quoted from http://www.businessweek.com/news/2012-01-20/novartis-s-gilenya-pill-reviewed-by-eu-u-s-after-11-deaths.html
Novartis’s Gilenya Pill Reviewed by EU, U.S. After 11 Deaths
January 20, 2012, 12:27 PM EST
By Simeon Bennett
Jan. 20 (Bloomberg) -- European and U.S. regulators are reviewing Novartis AG’s Gilenya pill for multiple sclerosis after reports of 11 deaths among patients who took the drug. The shares fell the most in more than five months.
The reports raise concern that Gilenya, the first oral treatment for the debilitating neurological disease, may harm the heart, the European Medicines Agency said in a statement today. The U.S. Food and Drug Administration said it’s also reviewing data on the medicine.
Novartis said last month a patient died Nov. 23 after starting treatment with Gilenya. Ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm, the London-based EMA said. It isn’t clear what role if any Gilenya had in the deaths, it said.
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