FDA Study: Dabigatran Associated With Lower Stroke, Death Risk but Higher GI Bleeding Risk Compared to Warfarin

The U.S. Food and Drug Administration (FDA) notified health care professionals that a recent FDA study comparing dabigatran (Pradaxa) to warfarin in more than 134,000 Medicare patients found that “Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin.” However, the study also found that use of dabigatran increased the risk of major gastrointestinal bleeding as compared to warfarin. The risk of myocardial infarction (MI) was comparable for both drugs.

The FDA noted that these findings, with the exception of the MI results, are consistent with the clinical trial results that were used as the basis for dabigatran’s approval. Therefore, the FDA is not making any changes to the current label or recommendations for use.

“Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label,” noted the FDA.

Clinical Topics: Anticoagulation Management, Novel Agents

Keywords: Benzimidazoles, beta-Alanine, Brain, Hemorrhage, Medicare, Myocardial Infarction, Pyridines, Stroke, United States Food and Drug Administration, Warfarin

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