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Xarelto Studies Point to Uncontrollable Bleeding Events, Meanwhile Lawsuits Mounting

Jul 12, 2016

Drug thinner, Xarelto (rivoxaban), marketed jointly by Bayer AG and Janssen Pharmaceuticals, a division of Johnson & Johnson, has been the focus of a growing number of lawsuits. To date, thousands of Xarelto lawsuits have been brought over similar allegations.

Xarelto is part of a "new generation" or new class of blood thinners that are known as direct thrombin inhibitors. This group of medications also includes Eliquis and Pradaxa and has been approved to reduce the risk of blood clots in patients who are undergoing hip replacement surgery, to prevent blood clots in patients diagnosed with atrial fibrillation, and to treat deep vein thrombosis (DVT) and pulmonary embolism.

The U.S. Judicial Panel on Multidistrict Litigation (MDL) has consolidated approximately 2,800 individual cases into MDL case number 2592, which 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 patients and their physicians not being provided with an antidote, or reversal agent, for potential uncontrolled bleeding events that may occur in some patients.

Some allege that Bayer and Janssen marketed Xarelto without fully disclosing its dangers. Lawsuits also allege that the companies touted Xarelto as a better alternative to Coumadin (warfarin). Coumadin is a long established blood thinner that, when taken, requires routine 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 experience warfarin uncontrolled bleeding events are treated with vitamin K infusion.

Soon after its release, Xarelto's potentially serious side effects were revealed. Emerging studies found a possible tie to spontaneous and severe bleeding episodes such as stomach bleeds and vitreous hemorrhage (bleeding of the eyes). One of two notable studies, conducted by doctors John C. Hwang and Judy H. Hun, found that patients in their practice who were taking Xarelto experienced some significant health issues. Patients were between 70 and 89 years of age and had used the traditional blood thinner Coumadin initially, later changing to Xarelto. The physicians noticed that the patients were, increasingly, 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 revealed that research involving the different blood thinners was unable 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.

Prior, in September 2013, Germany's Federal Institute for Drugs and Medical Services received 958 complication reports tied with Xarelto during the first eight months of the year. Of those complaints, 72 involved fatalities. In 2012, Xarelto was associated with 750 adverse event and 58 deaths. In the United States, according to findings published by the Institute for Safe Medical Practices (ISMP), its May 2014 QuarterWatch report, 680 complication reports were received during the first quarter of 2013.

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