Risk of Xarelto Bleeding Events, Deaths Evaluated in New Study

The findings of new research highlight the serious side effects of Xarelto, indicating that the new-generation anti-coagulant may be associated with a fatal bleeding rate of 0.08 per 100 person-years of use, and that 2.86 major bleeding events will occur every 100 person-years. 

In a study published by the medical journal Clinical Cardiology on January 14, researchers from Baylor College of Medicine, a number of other U.S. universities and Janssen Pharmaceuticals indicate that the findings are consistent with those in clinical trials that first led to the drug’s approval.

The study was funded by the manufacturers of Xarelto, Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary, looking at data from U.S. Department of Defense health care records from January 1, 2013 to March 31, 2014.

According to the findings, out of 27,457 patients who received Xarelto during that time, there were 496 major bleeding events among 478 patients, meaning some had more than one event. That translates to 2.86 incidents per 100 person-years. They also found that at least 14 patients died of major bleeds during the study, which translates to a fatal bleeding incidence rate of 0.08 per 100 person-years.

The study comes about a month after Canadian researchers published a report indicating that Xarelto and Pradaxa, both new blood thinners designed to compete with warfarin, carried about the same risk profile as warfarin, despite marketing indicating that the drugs were safer alternatives.

Xarelto Bleeding Risks

Xarelto (rivaroxoaban) is a member of a new generation of blood thinners, known as “Factor Xa” anticoagulants, which have been aggressively promoted the drugs as safer and easier to use than warfarin, which has been the go-to treatment for decades to prevent strokes or blood clots among patients with atrial fibrillation.

While Coumadin (warfarin) is widely available as a generic and substantially less expensive than the new medication, the manufacturers have encouraged doctors to switch patients by suggesting that Xarelto is safer and easier to use, without the need for blood monitoring during treatment. However, recent studies have raised concerns about those claims, suggesting that blood monitoring on Xarelto may actually reduce the risk of severe bleeding problems.

As the popularity of Xarelto has increased, concerns have emerged about the bleeding risk, as large numbers of patients and doctors have reported incidents of uncontrollable hemorrhaging or bleeds, that may result in severe injury or death.

While all blood thinners carry a risk of bleeding problems, Xarelto and other members of this new generation of anticoagulants currently lack an approved antidote that doctors can use to reverse the effects of the drug. While doctors can quickly stop the blood thinning effects of warfarin, there is no Xarelto antidote, leaving physicians unable to stop bleeding problems that may occur during use, which may increase the risk of more severe injury or death.

Bayer and Janssen now face a growing number of Xarelto lawsuits, which allegations that the drug makers placed their desire for profits before the safety of consumers by aggressively marketing the drug without adequate warnings, and for failing to fully explore all potential reversal agents that may have made the medication safer. Many plaintiffs also allege that the benefits provided by the medication do not justify the risks, indicating that the drug makers should issue a Xarelto recall until a reversal agent can be developed.

Last month, a panel of federal judges ordered the centralization of all Xarelto bleeding lawsuits, transferring cases filed throughout the federal court system to one judge in Louisiana for coordinated pretrial proceedings.