FDA Stops Study, Issues New Warning for Pradaxa

December 20, 2012 — The U.S. Food and Drug Administration (FDA) has published a Safety Announcement to warn that Pradaxa (dabigatran), a popular new blood-thinning medication, should not be prescribed to patients with mechanical heart valve replacements due to an increased risk of strokes, heart attacks, major bleeding, and blood clots forming on the valve. According to the FDA, “The RE-ALIGN trial was terminated early because thromboembolic events and major bleeding were significantly more frequent in the Pradaxa treatment arm than in the warfarin treatment arm.”

The study involved 160 people who started taking Pradaxa within 3 days after surgery to implant a mechanical heart valve, and 89 who started taking warfarin. It was halted about three weeks ago.

The study found that 22.5% of Pradaxa patients suffered bleeding, compared to 13.5% of warfarin patients. They also found that 5% of Pradaxa patients suffered strokes, and 2% suffered heart attacks, but there were no strokes or heart attacks in the warfarin group. Major bleeding events were almost four times as common in the Pradaxa group.

The FDA has only approved Pradaxa to prevent stroke and blood clots in patients with non-valvular atrial fibrillation, which is a type of irregular heart rhythm. Doctors may be tempted to prescribe Pradaxa to patients with mechanical valves because these patients have a high risk of blood clots forming around the valve.

The FDA will add a contraindication (warning against use) for Pradaxa in patients with mechanical heart valves. Pradaxa patients with the valves should talk to their healthcare professional as soon as possible to discuss the best anticoagulation therapy.

Pradaxa (dabigatran) is a blood-thinning medication that was created by the drug company Boehringer Ingelheim. It was approved by the FDA in 2010, and since then, it has quickly become a popular alternative to warfarin, a blood-thinner that has been on the market since the 1950s.

The problem with Pradaxa is that it lacks an effective reversal mechanism, which can be life-threatening in a bleeding emergency. Whereas the blood-thinning effects of warfarin can be reversed with a dose of Vitamin K, Pradaxa can only be reversed with several hours of dialysis.

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