Background: four new PO anticoagulant meds – three are Xa inhibitors, and dabigatran is a direct thrombin inhibitor. Major bleeding has been less common compared to warfarin, but there have not been antidotes or reversal options available.
Approved Oct 16 2015
Monoclonal Ab fragment that binds to dabigatran, blocking its anticoag ability
Approval based on trial in healthy volunteers and a study of patients requiring urgent reversal due to bleeding or need for surgery. (Lancet 2015;386:680)
Ongoing trial: 89% of 123 patients had complete reversal of dabigatran effect within 4 hours of getting tx.