Dabigatran (Pradaxa ) is an oral anticoagulant from the class of the direct thrombin inhibitors. It is oral and offers an alternative to warfarin. Unlike warfarin(Coumadin) it does not require frequent blood tests for international normalized ratio (INR) monitoring while offering similar results in terms of efficacy. On the other hand, there is no specific way to reverse the anticoagulant effect of dabigatran in the event of a major bleeding event, unlike warfarin. The U.S. Food and Drug Administration (FDA) approved Pradaxa on October 19, 2010, for prevention of stroke in patients with non-valvular atrial fibrillation. On December 7, 2011, the FDA initiated an investigation into serious bleeding events associated with dabigatran stating that the “FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa [RE-LY trial].”
It is far from clear that it is a better alternative than older anti-coagulants in the settings of chemotherapy of stem cell transplantation.
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