FDA Safety Alert Reaffirms Benefits of New Anticoagulation Therapy Despite Risks

​New evidence indicates that, compared with warfarin therapy, the use of Pradaxa (dabigatran) among patients new to anticoagulants may be associated with a lower risk of clot-related strokes, bleeding in the brain, and death, states a May 13, 2014, safety alert from the U.S. Food and Drug Administration (FDA). However, researchers also found an increased risk of major gastrointestinal bleeding when using Pradaxa as compared with warfarin.