Xarelto Side Effects More Likely to Result in Death than Warfarin for Afib Patients with Heart Disease: Study

The findings of a new study suggest warfarin is a better blood thinner for atrial fibrillation patients with rheumatic heart disease than its newer competitor, Xarelto, which carries side effects that may increase the risk of patient death.

A group of researchers from around the world, known as the INVICTUS investigators, published a study this week in the New England Journal of Medicine, which compared Xarelto (rivaroxaban) to warfarin among patients with rheumatic heart disease-associated atrial fibrillation. They found that the potential Xarelto side effects may make patients less likely to survive as long as those given warfarin.

Xarelto is a member of a relatively new class of drugs which have been marketed as a replacement for warfarin, which has been the go-to blood thinner for decades. However, Xarelto was linked to risks of severe and uncontrollable bleeding events before reversal agents were introduced in 2018. Warfarin, by comparison, has always been able to be reversed through the use of vitamin K, and is known as a vitamin k antagonist.

In this latest study, researchers enrolled 4,565 patients into a study comparing the use of Xarelto versus the use of warfarin. They looked at data on the number of strokes, and other atrial fibrillation health risks among those patients.

According to their findings, Xarelto users were more likely to permanently discontinue the drug, and the restricted mean survival time for Xarelto patients was 1,599 days, compared to warfarin patients, who lived 1,675 days: or 76 days longer than Xarelto patients.

The researchers found 560 Xarelto patients suffered some form of primary adverse event, such as stroke or death; compared to only 446 of those given warfarin. However, there was no significant difference in rates of bleeding events linked to both drugs, they determined.

“Among patients with rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy led to a lower rate of a composite of cardiovascular events or death than rivaroxaban therapy, without a higher rate of bleeding,” the researchers concluded.

Xarelto Litigation

Incidents of unstoppable bleeding have resulted in thousands of reports involving injury or death for patients using the new drugs. About 30,000 Xarelto lawsuits were filed against the drug makers, alleging that users and the medical community were not adequately warned about the risk of problems linked to the drug.

Following a handful of early bellwether trials, which were held before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to help gauge how juries may respond to certain evidence and testimony that was likely to be repeated throughout the litigation, a global Xarelto settlement was reached in March 2019, resolving nearly all claims.