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FDA: Pradaxa Not for Patients With Mechanical Heart Valves

Last Updated: December 20, 2012.

Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, according to a Dec. 19 safety announcement issued by the U.S. Food and Drug Administration.

THURSDAY, Dec. 20 (HealthDay News) -- Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, according to a Dec. 19 safety announcement issued by the U.S. Food and Drug Administration.

The RE-ALIGN trial was recently stopped because Pradaxa users were found to be more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. In addition, more bleeding after valve surgery was found in the Pradaxa users than in the warfarin users.

The FDA is requiring a contraindication of Pradaxa in patients with mechanical heart valves. The FDA recommends that health care professionals 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 [valve], has not been evaluated and cannot be recommended," according to information from the FDA. "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."

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