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Side effects of Xarelto, Pradaxa, Eliquis, Warfarin and Heparin may actually increase the risk of stroke among some patients with atrial fibrillation, instead of preventing them as they were designed to do, according to the findings of a new study.
Researchers from the U.K. published a study last week in the medical journal The BMJ, warning that for older afib patients with chronic kidney disease, the use of some blood thinners may actually increase the risk of stroke instead of reducing it.
The study looked at data on 6,977 patients who had received an atrial fibrillation diagnosis. Researchers found that 2,434 of those patients were prescribed either a vitamin K agonist, like warfarin, direct oral anticoagulants like Xarelto, Pradaxa or Eliquis, or Heparin within 60 days of their diagnosis. The rest were not.
Patients who were given blood thinners of any type who had chronic kidney disease had more than double the risk of ischaemic stroke and hemorrhage, but there was no increased risk in all cause mortality, the researchers found. In fact, the risk of death decreased slightly when compared to those given no blood thinner prescription.
“Giving anticoagulants to older people with concomitant atrial fibrillation and chronic kidney disease was associated with an increased rate of ischaemic stroke and haemorrhage but a paradoxical lowered rate of all cause mortality,” the researchers concluded. “Careful consideration should be given before starting anticoagulants in older people with chronic kidney disease who develop atrial fibrillation. There remains an urgent need for adequately powered randomised trials in this population to explore these findings and to provide clarity on correct clinical management.”
The researchers noted that the findings could have wide-ranging implications, given that up to 15% of adults globally develop chronic kidney disease, and that about a third of those cases also involve atrial fibrillation, which costs the U.S. healthcare system about $26 billion annually.
The study also comes amid ongoing concerns about the safety of the new generation of blood thinners, such as Xarelto, Pradaxa and Eliquis.
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.