Xarelto Bleeding Risk May Be Greater Than Pradaxa: Study

As a growing number of Xarelto lawsuits continue to be filed nationwide on behalf of individuals who experienced problems with uncontrollable bleeding, the findings of new research seem to suggest that the bleeding risk with the controversial anticoagulant may be higher than with its primary competitor, Pradaxa, which has also been the subject of similar lawsuits over failure to warn.

Xarelto and Pradaxa are both new-generation drugs introduced in recent years as alternatives to warfarin, which has been the go-to anticoagulation treatment among individuals with atrial fibrillation for decades.

While these newer medications are marketed as easier to use, concerns have emerged about the potential side effects of Xarelto and Pradaxa as many individuals have reported suffering problems with uncontrollable bleeding.

In a study published this week in the medical journal JAMA Internal Medicine, researchers compared the risk of stroke, intracranial hemorrhaging, major bleeds and death among elderly individuals who received Xarelto or Pradaxa for nonvalvular atrial fibrillation.

Researchers evaluated data on nearly 120,000 patients who received one of the drugs between November 4, 2011 and June 30, 2014, indicating that the risk of bleeding with Xarelto was significantly increased.

According to the findings, Xarelto was associated with a 65% increased risk of intracranial hemorrhaging, a 48% increased risk of major extracranial bleeding, and a 40% increased risk of major gastrointestinal bleeding. There was also a 15% increased risk of mortality associated with Xarelto use, but the researchers found that difference to be statistically nonsignificant.

Unlike warfarin, where the blood thinning effects of the drug can be reversed quickly with vitamin K and fresh frozen plasma if bleeding problems develop, no safe and effective antidote has been approved for use with Xarelto and one has only been recently been approved for Pradaxa.

As a result of the drug makers’ failure to adequately warn about the bleeding risk, or disclose that reversal agents were not available for Pradaxa or Xarelto, lawsuits have been filed by thousands of individuals nationwide in recent years.

Following several years of litigation against Boehringer Ingelheim over the Pradaxa bleeding risk, the manufacturer agreed to pay $650 million to settle about 4,000 failure to warn cases.

Given the more widespread use of Xarelto, there are already more than 10,000 cases pending nationwide involving bleeding problems among users, and the litigation is expected to continue to grow over the coming months and years, as the manufacturers defend the cases in court.

A series of Xarelto bellwether trials are expected to begin early next year in the federal court system, which are designed to help parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes will not be binding on other claims, they may influence eventual Xarelto settlements that may be reached in the litigation.