Study Links Xarelto To Increased Risk of Strokes and Brain Bleeds: Study

Xarelto bleeding risks have been a problem since the drug was first introduced, which resulted in tens of thousands of Xarelto lawsuits which have since been resolved.

According to the findings of a new study, the side effects of Xarelto carry a higher risk of strokes and brain bleeds than its main blood thinning competitor, Eliquis.

Researchers from Vanderbilt University School of Medicine report that patients with atrial fibrillation given Xarelto (rivaroxaban) were more likely to suffer major ischemic or hemorrhagic events than those given Eliquis (apixaban). The findings were published on December 21 in the Journal of the American Medical Association (JAMA).

Both medications are part of a relatively new class of drugs that have been marketed as a replacement for warfarin, which has been the go-to blood thinner for decades. However, both drugs have been linked to risks of severe and uncontrollable bleeding events, especially before reversal agents were introduced in 2018.

In this latest study comparing the two, researchers conducted a retrospective cohort study which used computerized enrollment and claims files for U.S. Medicare beneficiaries who were ages 65 or older. The study involved data on more than 580,000 patients with atrial fibrillation who began using Xarelto or Eliquis between January 1, 2013, and November 30, 2018.

Researchers looked at the population for instances of major ischemic events, such as strokes or systemic emboli, and major hemorrhagic events, such as intracerebral hemorrhage, intracranial bleeding and fatal extracranial bleeding.

According to the findings, those who took Xarelto had a higher risk of both major ischemic events and hemorrhagic events. Overall, researchers determined that 16.1 Xarelto strokes or brain bleeds occurred per 1,000 person-years, compared to only 13.4 per 1,000 person years among those who took Eliquis.

In addition, the researchers found Xarelto patients had an increased risk of fatal extracranial bleeding, nonfatal extracranial bleeding, fatal strokes and brain bleeds and had a higher total mortality rate than those taking Eliquis.

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The findings echo those of a study published earlier this month in the Annals of Internal Medicine by researchers from the University of Pennsylvania, who found that the risks of recurrent venous thromboembolism and bleeding events were higher with Xarelto than with Eliquis.

“In this retrospective cohort study that included 581 451 patients 65 years or older enrolled in Medicare with atrial fibrillation, the adjusted incidence of major ischemic or hemorrhagic events was 16.1 per 1000 person-years for rivaroxaban vs 13.4 per 1000 person-years for apixaban, a difference that was statistically significant,” the researchers determined. “Among older adults with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.”

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.


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