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In February 2014, Kentucky resident Virginia Stuntebeck filed a new Xarelto lawsuit against drug manufacturers Johnson & Johnson (J&J) and Bayer AG. The case is pending in the Pennsylvania Court of Common Pleas.

The plaintiff claims that after taking the anticoagulant, she suffered serious injuries and had to go to the hospital. Since her complaint was filed, several more plaintiffs have come forward with similar claims concerning Xarelto.

Plaintiff Lands in Hospital Months After Starting Xarelto

Stuntebeck started taking Xarelto (rivaroxaban) in July 2012 to treat her non-valvular atrial fibrillation. This condition increases risk of blood clots. The FDA approved Xarelto for treatment of the condition in November 2011. Xarelto works as an anticoagulant, reducing the risk of blood clots, stroke, and systemic embolism. In 2012, the FDA expanded the use of the drug to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism, as well.

Several months after Stuntebeck started taking the medication, in February 2013, she landed in the hospital for severe internal and gastrointestinal bleeding. She underwent treatment for several days for a condition she blames on Xarelto.

More Convenient, but More Risky?

Manufacturers of Xarelto have advertised it as a more convenient option, compared to warfarin (Coumadin), which was the main anticoagulant available until a few years ago. Whereas warfarin requires regular blood monitoring and dietary changes, Xarelto comes in a convenient once-daily dose that does not require other lifestyle adjustments.

In the original clinical trials used to gain FDA approval, researchers discovered that patients taking Xarelto had more gastrointestinal bleeds than those taking warfarin, and needed more transfusions. Stuntebeck and other plaintiffs who have filed lawsuits against J&J and Bayer have noted that this fact should have been more visible on the product warnings.

No Readily Available Antidote

The Institute of Safe Medication Practices QuarterWatch report, issued October 3, 2012, revealed 158 cases of blood clots had been reported in relation to Xarelto. In the next report, issued January 9, 2013, it was noted that three drugs—warfarin, Pradaxa, and Xarelto—accounted for 1,734 reports of adverse events, including 233 deaths, “reinforcing the conclusion that anticoagulants rank among the highest risk of all outpatient drug treatments.”

One of the main issues with both Xarelto and Pradaxa is the lack of a readily available antidote for excessive bleeding. Whereas warfarin bleeds can be reversed with injections of vitamin K, the other two drugs have no such solution, which makes side effects much more serious and potentially deadly. Plaintiffs who have filed Xarelto lawsuits claim that the manufacturers should have placed a black box warning on the labels warning doctors and patients of the potential seriousness of “irreversible bleeds.”

The FDA approved a reversal agent in May 2013, called “Kcentra.” The drug will help prevent patients taking warfarin from bleeding to death—as an alternative to vitamin K—but unfortunately, it doesn’t work with newer anticoagulants like Pradaxa and Xarelto.

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