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Xarelto Plaintiffs Cite Research Findings to Support Allegations

Jun 24, 2016

A federal multidistrict litigation (MDL) is underway consolidating lawsuits alleging that the blood thinner Xarelto caused unnecessary and irreversible bleeding. Plaintiffs in the litigation allege that Bayer Healthcare and Janssen Pharmaceuticals, a division of Johnson & Johnson, failed to warn about the risk of life-threatening complications. The suits cite a number of pieces of evidence to support these allegations, among them are two studies. There are over 2,800 cases centralized to the MDL.

The U.S Food and Drug Administration (FDA) approved Xarelto in 2011 to reduce the risk of blood clot and stroke in patients with conditions such as atrial fibrillation, deep vein thrombosis and pulmonary embolism; it was also approved for patients who recently underwent hip or knee replacement surgeries. Xarelto, along with drugs such as Pradaxa, were touted as a new generation blood thinner. The traditional treatment before these drugs was warfarin, which requires regular blood monitoring and dietary restrictions.

All blood thinners generally carry some risk of bleeding. With Xarelto and other new generation blood thinners, however, there is no antidote to reverse the bleeding if it starts. This is not the case with warfarin, a point highlighted in many Xarelto cases. Plaintiffs allege they were never warned about the risk of uncontrollable bleeding.

Xarelto lawsuits cite two particular studies, one authored by Drs. Judy Hun and John Hwang in JAMA Ophthamology in June 2015. The physicians noticed a potential increased risk in their own practice; patients who switched from warfarin to Xarelto appeared to have higher rates of eye bleeding, or vitreous hemorrhages. "In all cases, an acute vitreous hemorrhage occurred shortly after rivaroxaban (Xarelto) treatment was initiated." they stated.

Plaintiffs also cite another study, published in the April 2015 issue of BMJ. Researchers studied a sample of 46,000 patients taking Xarelto, Pradaxa or warfarin and found that Xarelto was associated with an increased risk of gastrointestinal bleeding compared to warfarin.

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