December 20, 2012 — The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that the anticoagulant Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical 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.
Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with nonvalvular atrial fibrillation (AF), a common heart rhythm abnormality that causes the upper 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 FDA said clinicians 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 has not been evaluated and cannot be recommended. 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 healthcare professional.