FDA Approves Pradaxa as Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation

By Mellanie True Hills

October 19, 2010 — The day the afib community has awaited has finally arrived — the FDA has just approved Pradaxa (dabigatran), the first alternative to Coumadin (warfarin), for preventing afib-related strokes in those with atrial fibrillation.

On September 20, 2010, the FDA’s Advisory Committee recommended unanimously that the FDA approve dabigatran, and the FDA approval has just been announced barely a month later. The FDA has approved dabigatran on the strength of the results of the Randomized Evaluation of Long-Term Anticoagulant Therapy trial, known as the RE-LY trial, in which patients on Pradaxa had fewer strokes compared to those on warfarin. Find out more information about the RE-LY trial in Dabigatran Better than Warfarin for Stroke Prevention in Atrial Fibrillation.

According to the FDA’s press release today: “People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.”

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Disclaimer: Patients come first at StopAfib.org, and we do not compromise on that. However, even though Boehringer Ingelheim, the maker of Pradaxa, is a donor to StopAfib.org, we believe that this news is so significant for the afib community that we absolutely must share it immediately.

Mellanie True Hills is the founder and CEO of StopAfib.org and is an atrial fibrillation survivor.