FDA study of Medicare patients finds risks lower for stroke and death but higher for GI bleeding with Pradaxa vs. warfarin

05/14/2014 | Forbes

An FDA study that included 134,000 Medicare patients showed the blood thinner Pradaxa (dabigatran) was linked to a lower risk of ischemic stroke, brain bleeding and death compared with warfarin (Coumadin, Jantoven and generics), but an increased risk of major gastrointestinal bleeding. The study found no differences in heart attack risk between the drugs, which are used to reduce stroke and blood clot risks in non-valvular atrial fibrillation patients. The FDA said dabigatran has "a favorable benefit to risk profile" but that it will continue to study its GI risks.

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