Nov. 12 (Bloomberg) -- Boehringer Ingelheim GmbH said its blood-thinner Pradaxa has been linked to 260 deaths worldwide.
Boehringer “takes all reports about side effects and deaths very seriously and continuously monitors the use of all its medication including Pradaxa,” Klaus Dugi, senior vice president for medicine, said in a statement on the company’s website today. Earlier this month, the Ingelheim, Germany-based company said the number of deaths among Pradaxa patients was probably about 50.
Boehringer received approval in Europe this year and in the U.S. last year to sell Pradaxa for patients with atrial fibrillation, an irregular heartbeat that can increase the likelihood of a stroke. Pradaxa was more effective than warfarin, the previous standard of care, in a study of about 18,000 patients. The reported number of deaths so far is fewer than would have been expected from the results in the trial, called RE-LY, the company said.
Spiegel Online reported earlier today that the European Medicines Agency was notified of 256 deaths worldwide related to Pradaxa. Of those, 21 deaths were reported in Europe, including four in Germany, Spiegel Online said.
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