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The findings of a new study suggest that side effects of Savaysa may increase the risk of major bleeding events, while providing users about the same effectiveness as low-molecular weight heparin in prevention of venous thromboembolism events.
Researchers with the University of Oklahoma Health Sciences Center published a study this month in the New England Journal of Medicine, which indicates that the novel oral anticoagulant Savaysa was non-inferior to low molecular weight heparin, known as dalteparin, but appears to carry an increased bleeding risks. The study was funded by Daiichi Sankyo, the manufacturer of the new medication.
Savaysa (edoxaban) is part of a new generation of blood thinners, which also includes the controversial medications Xarelto, Pradaxa and Eliquis, which are prescribed for the prevention of strokes from atrial fibrillation. However, the drugs have been linked to reports of uncontrollable bleeding problems, since they were released without reversal agents that doctors can use to quickly stop the blood thinning effects if problems arise. The drugs are meant to replace warfarin, an older blood thinner whose effects can be quickly halted with vitamin K and fresh plasma.
In this latest study, researchers looked at the effectiveness of Savaysa in preventing blood clot events known as venous thromboembolism when compared to dalteparin. The study involved a randomized, open-label trial that included 1,050 patients.
About 8% of Savaysa patients in the study suffered recurrent venous thromboembolism problems, compared to 11.3% of dalteparin patients. However, nearly 7% of Savaysa patients suffered major bleeding events, compared to only 4% of dalteparin patients.
“Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding,” the researchers concluded. “The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin.”
Blood Thinner Concerns
Similar blood thinners, like Xarelto, have been the subject of serious safety concerns, as the drugs have been linked to a number of adverse event reports involving uncontrollable bleeding. Those concerns have resulted in thousands of lawsuits, mostly aimed at Xarelto over the last two years.
More than 18,000 Xarelto lawsuits have been filed against Bayer Healthcare and Janssen Pharmaceuticals, indicating that the drug makers provided inadequate warnings and precautions for users and the medical community.
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 withheld information about the lack of an antidote, and failed to recommend necessary monitoring to reduce the risk of 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.