Pradaxa (dabigatran etexilate mesylate) — not for use in patients with mechanical heart valves

Pradaxa (dabigatran etexilate mesylate) should not be used to prevent major thromboembolic events in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.

A clinical trial in Europe (the RE-ALIGN trial) was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.

Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.  FDA is requiring a contraindication of Pradaxa in patients with mechanical heart valves.

Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. The use of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been evaluated and cannot be recommended.

Health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

FDA safety alert