Pradaxa Has Higher Risk of Gastrointestinal Bleeding Compared to Warfarin, FDA Finds

The Food and Drug Administration May 13 said it recently completed a study of Medicare patients that found a higher risk for gastrointestinal bleeding with the blood thinner Pradaxa (dabigatran) compared to warfarin.

Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF), the agency said. Pradaxa, which the FDA approved in 2010 8 PLIR 1354, 10/22/10, is manufactured by Germany-based Boehringer Ingelheim GmbH.

The study compared Pradaxa to warfarin for risk of ischemic or clot-related stroke, bleeding in the ...