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  • FDA Date: 12/19/2012

    Pradaxa (dabigatran etexilate mesylate) FDA Drug Safety Communication

    Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (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 (a warning against use) 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. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their health care professional as soon as possible to determine the most appropriate anticoagulation treatment. Patients should not stop taking anticoagulant medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood clots and stroke.

    FDA previously released a Drug Safety Communication about the risk of serious bleeding associated with the use of Pradaxa in patients with non-valvular atrial fibrillation (the population for which the drug is approved). FDA has not changed its recommendations regarding use of Pradaxa in the population for which it is approved.

    View the full FDA Drug Safety Communication on FDA.gov