Pradaxa Risk in Patients with Mechanical Heart Valves

On September 1, 2013, the New England Journal of Medicine published the results of the RE-ALIGN study, a randomized phase-two study to compare the use of Dabigatran, marketed as Pradaxa, with Coumadin use in patients with mechanical heart valves. The study was terminated early because of an excess of both thromboembolic and bleeding events in the Dabigatran group. Dabigatran is an anti-coagulant manufactured and marketed by German drug maker Boehringer Ingelheim as Pradaxa. The study found an increased risk of strokes & major bleeds with Pradaxa use in patients with mechanical heart valves. The authors of the study reported that the results of the study indicated that the drug is not appropriate as an alternative for the prevention of thromboembolic complications in patients who require anti-coagulation after the implantation of a prosthetic heart valve. As of December 19, 2012 the U.S. prescribing information for Pradaxa was updated to include a contraindication, warning and precaution for use in patients with prosthetic heart valves.  Importantly, any use of anti-coagulant therapy should be carefully discussed with the patient’s physician.

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