Study Suggests Xarelto May Double Gastrointestinal Bleeding Risk

Published on June 25, 2015 by Sandy Liebhard

A recently-published study suggests that people who take Xarelto may be twice as likely to suffer from gastrointestinal bleeding compared to those who use warfarin, a much older blood thinner that is sold under the brand name Coumadin. Internal bleeding, including gastrointestinal bleeds, are among the injuries alleged in hundreds of Xarelto lawsuits that have been filed on behalf patients who claim to have been harmed by the drug.

The study, which appeared in the British Medical Journal in April, looked at data on more than 46,000 patients. The final study sample included 1649 treated with Xarelto (rivaroxaban) and 39,607 using warfarin. The remaining 4,907 patients were treated with Pradaxa (dabigatran), another new-generation anticoagulant.

“Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin,”the authors of the study concluded.

Xarelto Bleeding Litigation

Xarelto is currently the focus of more than 550 product liability claims filed on behalf of patients who allegedly suffered serious complications, including gastrointestinal bleeding, due to its use. Marketing claims that purportedly positioned Xarelto as a superior alternative warfarin are a key issue in this litigation. Both warfarin and Xarelto have the potential to cause serious internal bleeding. However, plaintiffs in Xarelto lawsuits point out that there currently exists no approved means of reducing bleeding associated with Xarelto. However, bleeding from warfarin can be reduced via the administration of vitamin K.

The U.S. Food & Drug Administration (FDA) first approved Xarelto in 2011 to reduce the risks of blood clots in patients undergoing knee or hip replacement surgeries. Its approved uses have since been expanded to include prevention of strokes in people with atrial fibrillation, as well as the treatment of deep vein thrombosis and pulmonary embolism. The drug’s label includes a black box warning that contains information about the increased risk of blood clot formation after premature discontinuation of the medication in the absence of adequate alternative anticoagulation

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