FDA Warns Clinicians Against Prescribing Pradaxa to Patients with Heart Valves

The FDA is now warning that the anticoagulant dabigatran (also known by its brand name Pradaxa) should not be prescribed to prevent stroke or thromboembolic events in patients with mechanical (also known as mechanical prosthetic) heart valves. The warning is one that has already been issued to European doctors by the European Medicines Agency (EMEA).

The warning was announced just two weeks after the FDA’s recent decision to stop the RE-ALIGN trial. RE-ALIGN is a global, Phase II trial that was created to evaluate the safety and pharmacokinetics of Pradaxa in 400 patients who have mechanical heart valves. The 12-week study compared three doses of Pradaxa to warfarin in patients with both aortic valve replacements and mitral valve replacements. Investigators stopped RE-ALIGN because the Pradaxa users were more likely to experience strokes, heart attack, and thrombosis forming on the mechanical heart valves than were users of warfarin. There was also more bleeding after valve surgery in the Pradaxa users, according to the FDA.

In the United States, Pradaxa has been approved by the FDA for the treatment of non-valvular atrial fibrillation. The drug, which works by thinning the blood to prevent blood clots and strokes, was hailed because its use required no blood testing, and it quickly captured a large portion of the market. (See our related blog here) However, now the FDA is stressing that this does not include patients with atrial fibrillation caused by heart-valve problems.

According to the FDA,

health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication.

If you or a loved one has any type of prosthetic heart-valve replacement and are taking Pradaxa, you should talk to your doctor as soon as possible to determine the best anticoagulation treatment.