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New research suggests that the bleeding risks with Xarelto may be higher among those with atherosclerotic vascular disease, when compared to the use of aspirin, but does not result in any better cardiovascular outcomes for patients.
In a study this week in the New England Journal of Medicine, researchers looked at whether Xarelto (rivaroxaban) alone or in combination with aspirin would result in better outcomes in treating artherosclerotic vascular disease, a form of heart disease often caused by high cholesterol. The research was designed to compare the combination to the use of aspirin alone.
The double-blind clinical trial, known as COMPASS, involved more than 27,000 participants, some of which were given a combination of Xarelto plus aspirin, and others were given either aspirin or Xarelto alone. The researchers looked at rates of cardiovascular death, stroke or heart attack.
According to the findings, patients given both Xarelto and aspirin had fewer cardiovascular problems, however, they were 70% more likely to suffer major bleeding events. There was no difference in fatalities, however. The group given Xarelto alone had about the same rate of heart problems as those given aspirin alone, but also suffered far more major bleeding events, the researchers noted.
“Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone,” the researchers determined. “Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events.”
Xarelto Bleeding Lawsuits
The findings come about a month after a report warned that oral anticoagulants were linked to nearly 22,000 reports of serious injuries submitted to the FDA in 2016, and were associated with more than 3,000 reports of deaths.
The report concludes that harm from blood thinners was the highest priority drug safety problem of 2016, due to multiple factors, including the high rate of injury, their widespread use, and the seriousness of the injuries.
Of all of the oral anticoagulants examined, including both new and old drugs, Xarelto bleeding problems were the most common.
Xarelto (rivaroxoaban) is part of a new generation of novel oral anticoagulants and was introduced in 2011, as an alternative to Coumadin (warfarin), which has been the go-to anti-clotting treatment for decades. However, more than 18,000 Xarelto lawsuits have been filed against Bayer Healthcare and Janssen Pharmaceuticals, indicating that users suffered severe and uncontrollable bleeding events on the drug.
Given the similar questions of fact and law raised in the complaints, all federal cases are centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of an MDL or multidistrict litigation.
While all blood thinners may cause bleeding, the side effects of warfarin can be quickly reversed with a widely known antidote. However, there was no Xarelto reversal agent when the drug was introduced, and plaintiffs allege that Bayer and Johnson & Johnson failed to adequately warn users and the medical community about the lack of an antidote, which led to severe and uncontrollable bleeds.
Similar allegations were raised in thousands of Pradaxa lawsuits filed several years ago, as that other new-generation anticoagulant hit the market before Xarelto. However, the maker of that competing drug ultimately agreed to pay $650 million in Pradaxa settlements just before the first bellwether trials were set to begin, 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, the number of complaints has surpassed the number of claims involved in the Pradaxa litigation, as the drug has become more widely used in recent years.