Boehringer Ingelheim announced that the prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.

This update was a result from an interim analysis from the Phase 2 RE-ALIGN study in patients with mechanical prosthetic heart valve replacement, a patient group different than what the label currently indicates. The interim analysis showed an increased incidence of strokes, heart attacks, and blood clots in this specific population treated with dabigatran etexilate compared to warfarin. Also, there was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.

Health care professionals are recommended to promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. 

Pradaxa, a direct thrombin inhibitor, is currently indicated to reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation.

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