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Study Links Xarelto And Gastrointestinal Bleeding Risk


April 28, 2015 — The risk of gastrointestinal bleeding may be twice as high for patients taking the blood-thinning medication Xarelto compared to warfarin, according to a study published in the British Medical Journal.

Researchers looked at data on nearly 50,000 patients in the United States who took Xarelto (rivaroxaban), Pradaxa (dabagatratn), or Coumadin (warfarin) between October 2010 and March 2012. The study included 1,649 patients on Xarelto.

The authors of the study concluded:

“Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out … a more than twofold higher risk of bleeding with [Xarelto] compared with warfarin.”

Pradaxa was also linked to a higher rate of gastrointestinal bleeding compared to warfarin.

Several studies have linked newer blood-thinning medications with higher rates of intestinal bleeding. Two years ago, a study published in Gastroenterology linked Xarelto to a 50% increased risk.

The makers of Pradaxa have already settled lawsuits accusing them of downplaying the bleeding risks in order to boost sales. Hundreds of similar lawsuits involving Xarelto are still pending in state and federal courts.

The problem is that Xarelto has no effective reversal agent. In a bleeding emergency, when a patient develops a gastrointestinal hemorrhage, health providers may be unable to control excessive bleeding. Lawsuits claim Xarelto was improperly marketed as a “one-size-fits-all” medication without adequate warnings about side effects.


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