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Xarelto Associated with Increased Bleeding, Mortality Compared to Pradaxa

Xarelto has been linked to an increase in both intracranial and extracranial bleeding in elderly patients treated for nonvalvular atrial fibrillation.

The blood-thinner drug Xarelto (rivaroxaban) has been linked to an increase in both intracranial and extracranial bleeding in elderly patients treated for nonvalvular atrial fibrillation (a-fib) compared with Pradaxa (diabigatran), according to a new study published in JAMA Internal Medicine.

Free Confidential Lawsuit Evaluation: If you or a loved one developed bleeding complications after taking Xarelto, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

What’s the Problem?

October 7, 2016 – In addition to the increased bleeding associated with Xarelto, the study found that the drug reduced risk of thromboembolic stroke and increased risk for mortality compared to Pradaxa. However, the increase in intracranial hemorrhage with Xarelto outweighed reductions in stroke, according to David J. Graham, MD, MPH, from the Center for Drug Evaluation and Research at the U.S. Food & Drug Administration (FDA).

For the study, Graham and colleagues looked at a cohort of 118,891 patients who were enrolled in fee-for-service Medicare. The test subjects were aged 65 years or older and had nonvalvular a-fib. They were treated with either Xarelto (20 mg, once daily) or Pradaxa (150 mg, twice daily) from November 2011 to June 2014.

The researchers reported that 52,240 participants took Pradaxa and 66,651 took Xarelto. Results indicated that, compared with Pradaxa, Xarelto was linked to increases in:

  • Mortality (HR = 1.15; 95% CI, 1-1.32; P = .051)
  • Reductions in thromboembolic stroke (HR = 0.81; 95% CI, 0.65-1.01; P = .07)
  • Increases in intracranial hemorrhage (HR = 1.65; 95% CI, 1.2-2.26; P = .002)
  • Increases in major extracranial bleeding (HR = 1.48; 95% CI, 1.32-1.67; P < .001)
  • Increases in major gastrointestinal bleeding (HR = 1.4; 95% CI, 1.23-1.59; P < .001)

The researchers also noted that Xarelto was associated with significantly increased mortality in patients aged at least 75 years or patients with a CHADS2 score of at least 2.

“In this large direct comparison of patients with AF treated with dabigatran or rivaroxaban, rivaroxaban use was associated with statistically significant increases in the risk of [intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding, and possibly with increased mortality in older patients or those with higher baseline risk of stroke,” the researchers concluded.

Do I Have a Xarelto Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xarelto lawsuits. We are handling individual litigation nationwide and currently accepting new bleeding injury and death cases in all 50 states.

Free Case Evaluation: Again, if you were injured by Xarelto side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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