Xarelto Bleeding Risks Higher In Patients With Kidney Disease: Study

New research raises further concerns about the potential side effects of Xarelto, indicating that the new-generation anti-coagulant may increase the risk of major bleeding events among individuals with kidney disease. 

The study was presented last month at a meeting of the American Heart Association, with researchers at the Navy Medical Center in Portsmouth, Virginia indicating that the risk of major bleeding problems on Xarelto increased for patients with kidney disease, but not the risk of death.

Researchers looked at data on about 44,793 patients in the Department of Defense electronic medical records and found that 6,921 of those were diagnosed with renal disease. Of those with kidney problems, 312 had suffered major bleeding events. Among the 36,891 patients without kidney disease who were given Xarelto, 981 had major bleeding events.

The study suggests that the rate of major bleeding among atrial fibrillation patients given Xarelto who suffered from kidney disease was 4.52 per 100 person years, compared to only 2.54 per 100 person years among those who did not have kidney disease. However, the rate of death was 0.09 for both groups.

The average age of those who suffered major bleeding events was 78 in both groups, and about 85% of the bleeding events were gastrointestinal in both groups of the study. The research also found that 9.1% of the bleeding events were intracranial among those without kidney disease, compared to 5.1% among those with impaired renal function.

Patients with kidney disease were more likely to be given lower doses of Xarelto. The researchers also found that patients with both heart disease and kidney disease had even higher rates of major bleeding events.

Xarelto Bleeding Problems

Xarelto (rivaroxoaban) was introduced in 2011 as a new generation treatment for prevention of blood clots among individuals at risk for deep vein thrombosis (DVT) or pulmonary embolism. It is promoted as a superior replacement for Coumadin (warfarin), which has been the go-to anticoagulant treatment for decades. While the medication is easier to use and requires less frequent medical monitoring, Xarleto has been linked to a large number of bleeding problems since it hit the market.

While all blood thinners carry a risk of bleeding injury, the side effects of warfarin can be quickly reversed with a widely known antidote of bleeding occurs. However, there was no Xarelto reversal agent when the drug was introduced.

Bayer and Johnson & Johnson’s Janssen subsidiary, face at least 2,400 Xarelto lawsuits throughout the federal court system, which all involve similar allegations that Xarelto users suffered uncontrollable bleeding or other problems.

Since December 2014, the Xarelto litigation pending throughout the federal court system has been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation.

Complaints filed nationwide are centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to reduce duplicative discovery into common issues in the cases, avoid contradictory pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Similar claims were raised in the litigation over Pradaxa, which is another new-generation anticoagulant introduced in October 2010, one year before Xarelto hit the market.

More than 4,000 Pradaxa lawsuits were ultimately filed by users of that drug who suffered bleeding injuries. Following several years of litigation, the manufacturer of that medication ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.

As Xarelto bleeding lawyers continue to review potential cases for individuals prescribed the anticoagulant throughout the United States, it is expected that this litigation will involve many more cases than the Pradaxa litigation, as the drug has become more widely used in recent years.