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Amid continuing reports of severe and uncontrollable bleeding with Xarelto, new research suggests that the controversial anticoagulant may be no better than aspirin for preventing blood clots following hip or knee replacement surgery.
In a study published this month in the New England Journal of Medicine, Canadian researchers, compared the use of aspirin to Xarelto for the prevention of venous thromboembolism events, such as deep vein thrombosis and pulmonary embolism, finding little difference between the efficacy or safety of the two drugs.
Xarelto (rivaroxaban) is the leading member of a new generation of direct oral anticoagulants, which are marketed as superior alternatives to warfarin for prevention of blood clots with atrial fibrillation and other conditions. However, while warfarin’s blood thinning effects can be quickly reversed with vitamin K and plasma, Xarelto and similar new blood thinners, such Pradaxa and Eliquis, were not released with a reversal agent, and have been linked to thousands of reported injuries and deaths stemming from bleeding events that could not be stopped.
In this latest study, researchers conducted a multicenter, double-blind, randomized clinical trial involving 3,424 patients who underwent either total hip or knee arthroplasty, and compared the outcomes with aspirin and Xarelto, to see how the drugs fared at preventing pulmonary embolism and deep vein thrombosis, and their safety profiles.
According to the findings, venous thromboembolism occurred in 11 of the 1,707 patients given aspirin, and 12 of the 1,717 patients given Xarelto. Additionally, there were eight patients who suffered major bleeding events while undergoing aspirin treatment, compared to five in the Xarelto group.
“Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism,” the researchers concluded.
The findings come several months after a clinical trial comparing Xarelto to low-dose aspirin for the prevention of stroke and embolisms was halted due to major Xarelto bleeding problems among test subjects.
That study was stopped following recommendations of an Independent Data Monitoring Committee, which noticed the Xarelto bleeding rates and determined the trial may be dangerous to participants.
These studies come as more than 18,000 Xarelto lawsuits are being pursued against the drug makers, alleging that inadequate warnings were provided for consumers and doctors about the benefits associated with the drug, and potential bleeding risks.
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.