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Researchers warn that the side effects of Xarelto, Pradaxa, Eliquis, and other similar blood thinners appear to increase the risk of death among hospital patients suffering from brain bleeds, but do appear to be safer than their older competitor, warfarin.
In a study published last week in the Journal of the American Medical Association (JAMA), researchers from Duke University indicate that patients with intracerebral hemorrhage (ICH) given any kind of oral anticoagulant face an increased risk of dying while in the hospital, compared to patients not given blood thinners.
The findings come from a retrospective cohort study of 141,311 patients suffering from brain bleeds who were admitted to a hospital between October 2013 and December 2016. Researchers looked at whether those patients used oral anticoagulants (OACs) within seven days prior to arriving at the hospital. They also looked at whether the blood thinners the patients took were warfarin or a non-vitamin K antagonist oral anticoagulant (NOAC) such as Xarelto, Pradaxa or Eliquis.
The study found that 10.6% of patients took warfarin, 3.5% used one of the newer blood thinners, 28% took concomitant blood single antiplatelet agents, and 4.1% took duel antiplatelet agents.
According to the findings, the in-hospital mortality rates were 32.6% for warfarin and 26.5% for drugs like Xarelto and Pradaxa, while those taking no blood thinners had only a 22.5% mortality rate.
Researchers noted that while warfarin did carry a higher risk than the newer blood thinners, both groups were more dangerous to patients than not taking the blood thinners at all, and the researchers pointed out that there is no reversal agent for Xarelto and similar drugs, making bleeding events potentially more dangerous.
“The major concern regarding NOACs is a lack of specific reversal agents,” the researchers noted. “Immediate management is necessary for patients with life-threatening bleeding including ICH, and appropriate reversal agents should be administered.”
Blood Thinner Lawsuits
Over the last several years, the safety of Xarelto and other new-generation blood thinners has been heavily debated, as the drugs have been linked to a number of adverse event reports involving uncontrollable bleeding.
Xarelto, Pradaxa and Eliquis are part of a new generation of novel oral anticoagulants, which were introduced as superior alternatives to warfarin, which has been the go-to anti-clotting treatment for decades. However, thousands of Pradaxa lawsuits and Xarelto lawsuits have been filed against the makers of the medictaions, alleging that inadequate warnings were provided for 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 in more than 18,000 cases pending nationwide 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 Pradaxa cases, which were ultimately resolved as part of a $650 million in Pradaxa settlements just before the first bellwether trials were set to begin, with an average of about $150,000 per claim.