FDA Safety Communication: Pradaxa

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

/ Author:  / Reviewed by: Joseph V. Madia, MD

The US Food and Drug Administration (FDA) is informing healthcare 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)1 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.

FACTS ON PRADAXA (dabigatran etexilate mesylate)

  • Pradaxa is a blood-thinning medication 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 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.

FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves. Healthcare 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 valve, 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; 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.

Additional Information for Patients

  • If you have had a heart valve replacement and are taking Pradaxa, talk to your healthcare professional as soon as possible about your treatment. Do not stop using Pradaxa or other anticoagulants without guidance from your healthcare professional. Stopping anticoagulants suddenly may increase your risk of blood clots or a stroke.
  • Discuss any questions or concerns about Pradaxa with your healthcare professional.
  • Report any side effects you experience to your healthcare professional and FDA’s MedWatch program using the information in the link to the FDA webpage in the citation links at the bottom of this page.
Reviewed by: 
Review Date: 
December 20, 2012
Last Updated:
December 20, 2012