12-Nov-14 10:15 AM  CST

Pradaxa (Dabigartan) May be linked to Higher Incidence of Bleeding than Coumadin (Warfarin)

In a recent reported conducted by the University and published by the Journal of American Medical Association (JAMA) Internal Medicine, Pradaxa (dabigartan) was found to have a 30% higher risk of bleeding than Coumadin (warfarin). The study, which followed a large sample of the Medicare population, also found that Pradaxa (dabigartan) had a 58% higher risk for a major bleeding event when compared to Coumadin (warfarin).

The risk of a major bleeding event was significantly higher among African Americans, as well as patient with chronic renal disease. Rita F. Redberg, MD stated the bleeding findings with Pradaxa (dabigartan) were, “significantly greater than originally appeared at the time of FDA approval”. Pradaxa (dabigartan), a pro-drug, meaning about 6% of the drug is absorbed and the rest is excreted as waste, was approved by the FDA in 2010.

            The major concern with Pradaxa (dabigartan) is not as much the incidence of bleeding, which can manifest as a GI bleed, but rather the increased incidence for a major bleeding event, which often presents as an intracranial bleed. The GI bleeds are much easier to detect in patients than are intracranial bleeds, which makes the chance of finding them before they do irreversible harm almost impossible. Ultimately the safety of the patient should be the greatest factor when instituting a therapy that involves any anticoagulant.

 

 

 

 

References:

“Dabigartan” MedlinePlus, 07-15-14, http://www.nlm.nih.gov/medlineplus/druginfo/meds/a610024.html, referenced 07.November 2014

Phend, C. “Dabigartan: More Bleeds in Practice than Expected” 11-06-14, MedPage, http://www.medpagetoday.com/Cardiology/Prevention/48425, referenced, 7.November 2014


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Source: Sandy Andrews  

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