Loading...
Dabigatran (Pradaxa) is an oral anticoagulant approved for treating patients who have atrial fibrillation or venous thromboembolism. The most important adverse effect of the drug is bleeding, but a specific antidote to reverse this anticoagulant has not been available previously.
On October 16, 2015, the U.S. FDA approved idarucizumab (Praxbind), a monoclonal antibody fragment that binds tightly to dabigatran and nullifies its anticoagulant activity. Approval was based on data from a randomized, placebo-controlled trial in healthy volunteers and a study of patients requiring urgent reversal because of bleeding or need for a surgical procedure (JW Oncol Hematol Aug 2015 and Lancet 2015; 386:680). In addition, in an ongoing, open-label trial of patients with life-threatening or uncontrolled bleeding or who require emergency surgery or urgent procedures, 89% of 123 enrollees exhibited complete reversal of dabigatran within 4 hours of receiving idarucizumab.
FDA Office of Hematology and Oncology Products.Idarucizumab. 2015 Oct 15. (http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm467396.htm)
Comment
Four new oral anticoagulant drugs currently are available in the U.S: Three inhibit coagulation factor Xa, and one — dabigatran — is a thrombin inhibitor. Major bleeding with these drugs generally has been less common than with vitamin K antagonists such as warfarin, but prescribers must be able to rapidly reverse their anticoagulant activity when dangerous bleeding or drug overdosing occurs, or when patients require urgent surgery. Clinicians now can infuse idarucizumab to bind dabigatran, and an antidote (andexanet alfa) for the factor Xa–inhibiting drugs currently is in clinical trials.