According to a study from the U.S. Food and Drug Administration (FDA), Pradaxa (dabigatran), in comparison to warfarin, was associated with a lower risk of stroke and death, but an increased risk of major gastrointestinal bleeding. The risk for myocardial infarction was similar for the two drugs. In a statement, the FDA said, “[W]e still consider Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.” Read more.