BACKGROUND: The approval of the oral direct thrombin inhibitor, dabigatran 
etexilate, gave patients an alternative to oral anticoagulation with warfarin. 
Like all anticoagulants, the primary adverse event (AE) associated with 
dabigatran is bleeding. Until the FDA approval of idarucizumab, there had been 
no reversal agent for dabigatran-induced anticoagulation in patients with 
life-threatening or uncontrollable bleeding, or those requiring emergent 
procedures.
AREAS OF UNCERTAINTY: The primary purpose of this review is to summarize the 
safety and efficacy of idarucizumab, a monoclonal antibody fragment, and its use 
as a reversal agent for dabigatran.
DATA SOURCES: A literature search was conducted through MEDLINE (1946 to 
November week 1 2015) and Embase (1980-2015 week 46) using the search term 
idarucizumab. Clinicaltrials.gov was consulted for a comprehensive list of 
ongoing and completed studies. Additional studies were identified through 
bibliographical citations. Clinical trials in animals and humans published in 
English evaluating the safety and efficacy of idarucizumab for reversal of 
anticoagulant treatment with dabigatran were included for review.
RESULTS: Idarucizumab has been shown to significantly reverse the anticoagulant 
effects of dabigatran in both healthy volunteers and patients requiring a 
reversal agent because of either overt bleeding or an emergency surgery or 
invasive procedure. The most common AEs were headache, nasopharyngitis, back 
pain, skin irritation, hypokalemia, delirium, constipation, pyrexia, and 
pneumonia. Deaths reported in idarucizumab studies were attributed to either the 
index event or a preexisting comorbidity. Most adverse effects were minor, but 
21 serious AEs have been reported in the published data including thrombotic 
events.
CONCLUSIONS: Given the increased use of direct oral anticoagulants, such as 
dabigatran, a need for specific reversal agents exists. Idarucizumab has been 
shown to be safe and effective in the reversal of dabigatran-induced 
anticoagulation in patients requiring emergent or urgent surgery or in patients 
with severe bleeding.