Dabigatran Approved for Stroke Prevention in Atrial Fibrillation

Dabigatran Approved for Stroke Prevention in Atrial Fibrillation

The FDA has approved the oral anticoagulant dabigatran (Pradaxa) to prevent stroke and blood clots in patients with atrial fibrillation.

Approval follows the RE-LY trial, in which dabigatran was noninferior to warfarin in terms of a combined endpoint of stroke or systemic embolism. There were also fewer hemorrhagic strokes with dabigatran.

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," the director of the FDA's Division of Cardiovascular and Renal Products said in an FDA news release.

The drug, a direct thrombin inhibitor, will come with a medication guide to warn patients of the potential for serious bleeding. Other side effects include gastrointestinal symptoms.

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PS...docs have been waiting for this medication's approval for a long time...if you are on coumadin, you know what I mean...