New Bleeding Results Found in Pradaxa vs. Warfarin Research

Recently, a new United States Food and Drug Administration (FDA) study compared the risks, benefits and effectiveness of blood thinners Pradaxa (known as dabigatran) and warfarin (known by brand names Coumadin and Jantoven). Both carry heart attack risks and the FDA said the patient should consult a doctor before voluntarily stopping use of either medication.

The study found that Pradaxa carries fewer risks in the following arenas compared to warfarin:

• blood clotted related strokes
• bleeding in the brain
• death

However, Pradaxa has more risks of gastrointestinal (GI) bleeding than that of warfarin according to the study published on Daily RX.

For this study, FDA researchers reviewed the insurance claims of 134,000 Medicare patients aged 65 and older who were new users of Pradaxa and warfarin. This new study was larger than the pool of 10,000 done a few years back in 2012 and researchers were able to garner more results for risks to make a more efficient safety guideline.

The FDA said the following concerning this study: “As a result of our latest findings, we still consider Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use. Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death.”

According to the FDA, as of December 2013, over 940,000 patients were prescribed Pradaxa.

WeBleed will post updates as more information becomes available on the outcomes of this FDA study.

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