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Since 2010, three direct-acting oral anticoagulants (DOACs) have been approved by the FDA as alternatives to drugs such as warfarin and heparin for preventing stroke and systemic embolism in patients with atrial fibrillation (AF) and for treating and preventing venous thromboembolism (VTE). In 2014, the thrombin inhibitor dabigatran (Pradaxa) and the factor Xa inhibitor apixaban (Eliquis), which previously were approved for preventing stroke in patients with AF, gained approval for VTE treatment and prophylaxis. The factor Xa inhibitor rivaroxaban (Xarelto) already was approved for both indications. And another promising thrombin inhibitor, edoxaban (Savaysa), is in the pipeline.
Postmarketing reports on dabigatran have raised concerns about…