In the fall of 2015, idarucizumab became the first drug-specific antidote to an oral anticoagulant to receive regulatory approval from the US Food and Drug Administration. Anticoagulants are designed to inhibit the formation of blood clots and prevent thrombotic disorders, but they can increase bleeding risk in patients who experience trauma or illness or who undergo invasive surgical procedures. For this reason, traditional anticoagulants have antidotes that reverse their therapeutic effects, but newer oral anticoagulants lack specific reversal agents and that has proven a barrier to their use in patients with higher bleeding risk.
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