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The findings of a new study suggest that the side effects of Xarelto are associated with a much higher risk of brain bleeds when compared to aspirin, highlighting concerns about the safety of the new-generation anticoagulant.
In findings published last week in the medical journal JAMA Neurology, researchers from Taiwan found that the use of Xarelto appears to carry three times the risk of intracranial hemorrhage. However, the risk only came with doses of 15 to 20 mg when compared to use of aspirin.
Xarelto (rivaroxaban) is the leading member of a new generation of direct oral anticoagulants, which are marketed as superior alternatives for prevention of blood clots with atrial fibrillation and other conditions. However, the drug has been linked to thousands of reports involving severe and fatal bleeding events, after doctors were unable to reverse the blood thinning effects.
In this latest study, researchers looked at data on clinical trials of three months or longer from multiple databases up to May 2018. They compared the outcomes of a number of novel oral ant-coagulants, such as Xarelto, Pradaxa and Eliquis to aspirin, looking for incidents of intracranial hemorrhage.
According to the findings, only the 15 mg to 20 mg daily doses of Xarelto increased the risk of brain bleeds. The risk with those dosages was triple that of the risk from daily aspirin use. However, the same risks were not seen with the 10 mg Xarelto dose.
“A 15-mg to 20-mg dose of rivaroxaban once daily is associated with substantially increased risks of intracranial hemorrhage, while smaller daily doses of rivaroxaban and (Eliquis) were not, implying that risk increase is dose dependent,” the researchers concluded. “It may be worthwhile to conduct randomized clinical trials comparing specific NOACs in specific doses and aspirin in patients without atrial fibrillation, but with potential sources of cardiac emboli that could cause stroke.”
The study comes several months after another group of Canadian researchers found that Xarelto also did no better than aspirin at preventing blood clots following hip or knee surgery. That study was also published in the New England Journal of Medicine.
Incidents of unstoppable bleeding have resulted in thousands of reports involving injury or death for patients using the new drugs. Currently, there are about 20,000 Xarelto lawsuits pending as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana.
Each of the claims raise similar allegations that users and the medical community were not adequately warned about the risk of uncontrollable bleeding on Xarelto.
Following a handful of early bellwether trials, which were held before Judge Fallon to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, no progress has been made in negotiating Xarelto settlements or another resolution for the claims.
As a result, Judge Fallon recently ordered the parties to select 1,200 Xarelto cases for discovery, which may then be remanded back to U.S. District Courts nationwide for individual trial dates later this year.