Dabigatran Contraindicated for Heart Valves

On 12.20.12, the US Food and Drug Administration warned that dabigatran should not be used to prevent stroke in patients with mechanical heart valves. The FDA’s announcement was preceded by a Boehringer Ingelheim press release detailing the contraindication. Here is Boehringer’s new statement: “The safety and efficacy of PRADAXA in patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than 3 months prior to enrollment) was evaluated in the phase 2 RE-ALIGN trial. RE-ALIGN was terminated early because of significantly more thromboembolic events (valve thrombosis, stroke, transient ischemic attack, and myocardial infarction) and an excess of major bleeding (predominantly post-operative pericardial effusions requiring intervention for hemodynamic compromise) for PRADAXA vs warfarin. Therefore, the use of PRADAXA is contraindicated in patients with mechanical prosthetic valves.”