Food and Drug Administration (FDA) approved idarucizumab (Praxbind) for the reversal of the direct thrombin inhibitor dabigatran. 4 It is significant that patients with atrial fibrillation experiencing a major bleed from an FXa inhibitor have a 15%-20% 30-day mortality rate, with up to 48% mortality for those experiencing an intracranial hemorrhage.5, 6, 7, 8 In the event of extensive bleeding, an effective, widely available antidote for the anticoagulant is desired. However, harm from all oral anticoagulants remains a significant drug safety problem because of a high rate of injury, causing bleeding in 8%-19% of patients treated for a year.1, 2, 3 In 1 study, anticoagulants that predominantly included warfarin, rivaroxaban, dabigatran, and enoxaparin accounted for 17.6% of all emergency department visits for adverse drug events, which led to a 48.8% hospitalization rate. These agents have demonstrated either superiority or noninferiority for thromboembolic outcomes and a similar or statistically reduced risk for major bleeding compared with traditional anticoagulation in clinical trials for various indications. 1 Dabigatran is a direct thrombin inhibitor, whereas other direct oral anticoagulants work by inhibiting factor Xa (FXa Table 1). The use of direct oral anticoagulants has increased since dabigatran was made available in 2010, with an estimated 3.8 million patient-years of exposure by the end of 2016.

Andexxa trial