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Study Says Severe Bleeding More Common with Xarelto Than with Pradaxa

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According to a cohort study published recently in JAMA Internal Medicine, patients using Xarelto (rivaroxaban) are more likely to experience serious bleeding events than those taking Pradaxa (dabigatran).

To conduct the study, researchers reviewed the records of 118,000 Medicare patients with atrial fibrillation (AFib) who were taking either Xarelto or Pradaxa. The researchers concluded that there were more serious bleeding events, including intracranial and extracranial hemorrhage, associated with Xarelto than with Pradaxa. The scientists also noted that in 2014, Xarelto was prescribed to AFib patients in the U.S. two to three times more often than Pradaxa, perhaps due to a false belief that Xarelto poses less risk of major bleeding events than Pradaxa.

What is Xarelto?

Xarelto is an anticoagulant approved by the U.S. Food and Drug Administration (FDA) as a more convenient alternative to Coumadin (warfarin), the traditional blood thinner that has been used since the 1950s to prevent heart attacks, strokes, and blood clots.

While all blood thinners increase the risk of bleeding problems, Xarelto has been linked to an increased number of uncontrollable blood injuries, primarily because there is no approved antidote available for patients who use the medication, and many of the side effects have been severe because the bleeding cannot be effectively controlled. Although a reversal agent has been approved for Pradaxa, there is still no approved antidote for Xarelto.

Xarelto Lawsuits

Johnson & Johnson and Bayer AG face more than 18,000 lawsuits in the U.S. related to Xarelto and severe internal bleeding. Nearly 14,000 Xarelto lawsuits have been centralized in federal multidistrict litigation (MDL) in U.S. District Court, Eastern District of Louisiana, and several thousand more cases have also been filed in state courts in Pennsylvania, Delaware, and California.

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