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.”
Dec 24 2012
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