FDA Study: Pradaxa Has Higher Risk for Gastrointestinal Bleeding than Warfarin

FDA_Study_Pradaxa_Risk_for_Gastrointestinal_BleedingA study recently completed by the Food and Drug Administration (FDA) found an increased risk of major gastrointestinal bleeding with the blood thinner Pradaxa (dabigatran) compared to warfarin.

Pradaxa and warfarin (Coumadin) are prescribed 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). In the study, the two drugs were compared for the risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, heart attack, and death in more than 134,000 Medicare patients, 65 years or older, Drug Discovery and Development (dddmag.com) reports. For new users of a blood-thinning drug, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain and death, than warfarin, with similar heart attack risk for the two drugs.

Pradaxa is the first drug in a new class of drugs 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. Blood thinners cut the rate of fatal or debilitating strokes, but they increase the risk of internal bleeding, which can prove fatal, Reuters reports. A selling point for the new class of  blood thinners is that patients using them do not need the regular blood testing required 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.

This new study included a much larger and older patient population than in an earlier review of post-market data, and used a more sophisticated analytical method. At this time, the FDA still considers Pradaxa’s benefit-to-risk profile favorable and is not requiring changes to Pradaxa’s label or the recommendations for use, according to Drug Discovery and Development.


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