Xarelto, manufactured by Bayer AG and Janssen Pharmaceuticals, a division of Johnson & Johnson, is the subject of mounting lawsuits. In fact, lawsuits now number in the thousands and involve similar allegations.
The U.S. Judicial Panel on Multidistrict Litigation (MDL) has consolidated some 2,800 individual cases into MDL case number 2592. That MDL will be tried in the U.S. District Court for the Eastern District of Louisiana. A similar consolidation is pending in the Philadelphia Court of Common Pleas and involves over 600 cases consolidated in a mass tort. Allegations similarly include that plaintiffs and their physicians were not appropriately advised of the potential for elevated risks for sudden and dangerous bleeding episodes associated with Xarelto as well as not providing an antidote, or reversal agent, for potential uncontrolled bleeding events in some patients.
The U.S. Food and Drug Administration (FDA) granted approval to the so-called “new generation” anticoagulant in 2011. Xarelto was originally intended for use by individuals suffering from pulmonary embolism or deep vein thrombosis (DVT) and was also intended as a preventative measure for patients recovering from hip or knee replacement surgery. Xarelto’s approved uses were expanded soon after to treat people with atrial fibrillation, a heart condition that increases stroke risks.
Soon after its release, Xarelto’s potentially serious side effects were revealed. Emerging studies found a possible tie to spontaneous and severe bleeding episodes that include stomach bleeds and vitreous hemorrhage (bleeding of the eyes). One of two noteworthy studies, conducted by doctors John C. Hwang and Judy H. Hun, revealed that patients in their practice who were taking Xarelto experienced some significant health issues. The individuals were between the ages of 70 and 89 and had used the traditional blood thinner Coumadin (warfarin) initially, later changing to Xarelto. The physicians noticed that the patients were, more and more, suffering from vitreous hemorrhages and that the most significant eye bleeding occurred during the time in which patients were being weaned off warfarin and beginning Xarelto. Study results were published in the June 2015 issue of JAMA Ophthalmology; the physicians indicated that, “In all cases, an acute vitreous hemorrhage occurred shortly after rivaroxaban (Xarelto) treatment was initiated.”
Another study—involving nearly 46,000 patients and the blood thinners Xarelto, Pradaxa, and warfarin—published in the April 2015 issue of BMJ found that research involving the different blood thinners were not able to rule out an increased risk of stomach bleeding that was at least two-fold greater for those individuals taking Xarelto when compared to individuals taking Warfarin.
Some allege that Bayer and Janssen marketed Xarelto without fully disclosing its dangers. Lawsuits allege that the companies touted Xarelto as a better alternative to Coumadin. Coumadin is a decades old blood thinner that, when taken, requires blood monitoring and dietary restrictions. While Xarelto patients do not have to undergo these restrictions and monitoring, lawsuits allege that Xarelto carries risks for irreversible bleeding because of its lack of a reversal agent. Patients who take warfarin may experience bleeding reversal with vitamin K infusion.