Higher risk of bleeding events associated with concomitant use of amiodarone and direct oral anticoagulants

Clinical Question

For patients with atrial fibrillation, is the combined use of amiodarone with apixaban or rivaroxaban associated with a greater risk of bleeding-related hospitalizations?

Bottom line

In this study, the concomitant use of amiodarone with a DOAC, compared with either sotalol or flecainide plus a DOAC, by older patients with atrial fibrillation was associated with a higher risk of bleeding-related hospitalizations. Although the investigators used statistical methodology to balance baseline characteristics between the 2 groups, it is possible that residual confounders remained, and that inherent differences in the patients who received amiodarone may have affected their bleeding risk. 2b

Study design: Cohort (retrospective)

Funding: Government

Setting: Inpatient (any location)


Nita Shrikant Kulkarni, MD
Assistant Professor in Hospital Medicine
Northwestern University
Chicago, IL

Discuss this POEM


Pieter Richard Verbeek

Higher risk of bleeding events associated with concomitant u

Amio and DOAC not an unusual combination for A-fib. It is unlikely that a clinical trial will ever be conducted to sort out the issue at hand. HR are concerning for severe side effects. While I would never make a switch in patient's medication away from amio I would consider pointing the concern out to a patient I saw in the ED with the advice they seek an opinion from their most responsible physician as to whether a change in medication out to be considered. Would be helpful if this results of the paper were confirmed using other patient populations.

Arup Kumar Dhara

Impact assessment



amiodarone and oral anticoagulants

good to know