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FDA Stops Study, Issues New Warning for Pradaxa

FDA Stops Study, Issues New Warning for Pradaxa

December 20, 2012 — Three weeks after halting a clinical study of Pradaxa (dabigatran) in heart valve surgery patients, the U.S. Food and Drug Administration (FDA) has issued a Safety Announcement to warn that heart attacks, strokes, bleeding, and blood clots are “significantly more frequent” in patients given Pradaxa instead of warfarin. Pradaxa is not approved to reduce the risk of blood clots in patients who have recently had heart valve replacement surgery, and it will now carry a contraindication to specifically warn against this use.

The European RE-ALIGN study involved nearly 250 patients who recently had surgery to implant a mechanical heart valve. Within 3 days of surgery, 160 were prescribed Pradaxa, and 89 were prescribed warfarin.

During the study, 13.5% of warfarin patients suffered bleeding, compared to 22.5% of Pradaxa patients. Pradaxa was also associated with a 5% risk of stroke and a 2% risk of heart attacks, but the warfarin group suffered no strokes or heart attacks. Pradaxa patients were also nearly 4 times more likely to suffer major bleeding than warfarin patients.

The FDA warned:

“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 Safety Communication did not address the outcome of the patients. One of the most important differences between Pradaxa and warfarin is that the blood-thinning effects of warfarin can be reversed with a dose of Vitamin K, but Pradaxa can only be reversed with several hours of dialysis. During a major bleeding event, this difference can be life-threatening.

The FDA is recommending that patients who are taking Pradaxa to reduce the risk of blood clots following heart valve replacement surgery should talk to their doctor as soon as possible.

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