Xarelto Bleeding Lawsuits Filed Against BayerJune 17, 2014 — Reuters reports that the first lawsuits involving Xarelto (rivaroxaban) have been filed against the German drug-maker Bayer AG.

The Frankfurter Allgemeine Zeitung, a newspaper in Germany, cited company sources as saying there were fewer than 10 lawsuits pending against Bayer. Bayer declined to comment except to say that Xarelto’s safety profile is consistent with clinical trials involving more than 75,000 patients.

Although only a small number of Xarelto lawsuits have been filed, lawyers expect that many more people who were injured will come forward to seek compensation. Hundreds of people have been injured by severe bleeding events. One of the most recent lawsuits was filed last month in Pennsylvania for a woman’s wrongful death.

Plaintiffs in the litigation allege that Bayer failed to adequately warn that Xarelto lacks an effective reversal agent — unlike warfarin, which can be reversed with Vitamin K, and Pradaxa, which can be reversed with dialysis.

Boehringer Ingelheim, the manufacturer of Pradaxa, recently agreed to pay a $650 million settlement to resolve up to 4,000 lawsuits pending against the company. Most of those lawsuits were centralized in a federal Multi-District Litigation (MDL No. 2385) in the Southern District of Illinois. Lawsuits involving Xarelto have not been centralized.

According to the Institute for Safe Medicine Practices (ISMP) QuarterWatch report for May 2014, there were 680 adverse events involving Xarelto reported to the U.S. Food and Drug Administration, surpassing reports for Pradaxa. Prescriptions for Xarelto have also outpaced Pradaxa by 2 to 1 by the end of last year.

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