The FDA is informing health care professionals and the public that the blood thinning medication 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 European clinical trial (the RE-ALGIN 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 were 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. The FDA is requiring a contraindication of Pradaxa in patients with mechanical heart valves.
Pradaxa is an anticoagulant used to reduce the risk of stroke and blood clots in patients with a specific condition called non-valvular atrial fibrillation (AF), a common heart rhythm abnormality that causes the upper heart chambers of the heart, or atria, to beat rapidly and irregularly. Pradaxa is not indicated for patients with atrial fibrillation caused by heart valve problems. 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.
Healthcare professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their healthcare 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.