Reviewed and approved by the AAEM Board of Directors (6/7/2017)
Dabigatran was approved by the Food and Drug Administration (FDA) in 2010 and was the first nonwarfarin oral anticoagulant (NOAC) to be introduced to the U.S. market. Dabigatran is a direct thrombin inhibitor that inhibits both free and fibrin-bound thrombin. Current indications include prevention and treatment of deep vein thrombosis and pulmonary embolism, non-valvular atrial fibrillation, and postoperative thromboprophylaxis. Dabigatran does not require routine monitoring like warfarin.
Shortly after its approval, patients began to present to emergency departments with bleeding events, some of which included severe gastrointestinal hemorrhage and intracranial hemorrhage. At the time of FDA approval, there was no antidote or known efficacious treatment for dabigatran-induced coagulopathy. In 2015, idarucizumab was approved by the FDA for dabigatran reversal. Idarucizumab is a monoclonal antibody fragment that binds specifically to dabigatran to neutralize the anticoagulant effect.  Other treatments, such as prothrombin complex concentrate (PCC), have also been used in an attempt to treat patients with severe dabigatran-associated hemorrhage. The purpose of this clinical practice statement is to evaluate the role of select reversal agents in the management of dabigatran-associated bleeding, understanding that other classes of oral anticoagulants exist and may have targeted reversal agents.