Dabigatran Etexilate Mesylate (Pradaxa®)
December 24, 2012
FDA is notifying the public and health care providers that the use of dabigatran etexilate mesylate (Pradaxa®) is contraindicated in patients with mechanical heart valves. The product labeling is being updated to include this contraindication.
A European clinical trial evaluating dabigatran and warfarin in patients with mechanical prosthetic heart valves was halted early due to increased risk of strokes, myocardial infarction, and valve thrombosis in the dabigatran arm compared with the warfarin arm. Patients in the dabigatran arm also experienced higher rates of bleeding events compared with patients in the warfarin arm.
Dabigatran is an anticoagulant labeled for use in patients with non-valvular atrial fibrillation, to reduce the risk of stroke. Dabigatran is not labeled for use in patients with atrial fibrillation due to heart valve problems.
Health care professionals are advised to transition patients who have mechanical heart valves and are taking dabigatran to an alternate agent. Additional information for healthcare professionals is available in the FDA Safety Announcement (see link below).
Patients who have undergone a heart valve replacement procedure and are taking dabigatran are urged to contact their health care professional immediately for clinical guidance. These patients should not discontinue dabigatran abruptly, but should follow the advice of their health care providers for transitioning to another anticoagulation treatment. Abrupt discontinuation of anticoagulants, including dabigatran, can increase the risk of thromboembolic events.
Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
December 24, 2012. University of Utah Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, Utah.