5/15/2014 11:43:03 AM
Boehringer Ingelheim GmbH said a new analysis of a company-funded study used to win approval of the blood thinner Pradaxa found 22 serious bleeding events that weren’t included in the original report. Additional events were found in patients in each of the three arms of the 18,000-patient study known as RE-LY. Five more complications were seen among those taking a 110-milligram dose of the drug, 11 among those on a 150-mg dose and six in the patients using warfarin. Pradaxa became the first alternative to warfarin, the standard of care for more than five decades for preventing strokes caused by blood clots, when it was approved in 2010 by the U.S. Food and Drug Administration.
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