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Pradaxa Carries Higher Risk for Gastrointestinal Bleeding than Warfarin

May 16, 2014

Results of a recently completed Food and Drug Administration (FDA) study of the blood-thinners Pradaxa (dabigatran) and warfarin found an increased risk of major gastrointestinal bleeding with Pradaxa as compared to warfarin.

Pradaxa and warfarin (Coumadin) are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF). The study compared the risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI) and death in more than 134,000 Medicare patients, 65 years or older, Drug Discovery and Development ( reports. Among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain and death, than warfarin. Heart attack risk was similar for the two drugs.

Pradaxa is one of a new class of medicines designed to replace warfarin, which has been prescribed for more than 50 years to prevent strokes in patients suffering from atrial fibrillation, a form of irregular heartbeat common among the elderly. While blood thinners cut the rate of fatal or debilitating strokes, they increase the risk of internal bleeding, which can prove fatal, according to Reuters. The new blood thinners have been welcomed because patients using them are not required to undergo the regular blood testing needed with warfarin. But new studies suggest that many Pradaxa users may in fact need such testing because they may have either too little or too much of the drug in their bloodstream, according to The New York Times.

The FDA notes that this study is based on a much larger and older patient population than studies used in an earlier review of post-market data. At this time, the FDA still considers Pradaxa to have a favorable benefit-to-risk profile and the agency has made no changes to Pradaxa’s label or the recommendations for use, according to Drug Discovery and Development.

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