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Amid aggressive promotion of the new-generation blood thinners as a superior replacement for warfarin, which has been the standard anticoagulant treatment for decades, new research suggests that side effects of Eliquis may actually increase the risk of stroke and embolism.
A study published this month in the medical journal The BMJ compared a number of new atrial fibrillation blood thinners, known as novel oral anticoagulants (NOACs), with warfarin, which has long been the go-to drug to prevent strokes from widespread heart condition.
Eliquis, Xarelto, Pradaxa and other new-generation anticoagulants have been introduced in recent years and marketed as easier to use than warfarin, indicating that they require less blood monitoring to maintain the proper dose. However, the drugs have also been linked to a large number of reports involving uncontrollable bleeding problems, as there was no safe and effective antidote for Xarelto, Eliquis or Pradaxa when they were introduced, often leaving doctors unable to stop bleeds that may occur.
Tens of thousands of Xarelto lawsuits, Pradaxa lawsuits and Eliquis lawsuits have been filed by individuals nationwide, alleging that the drug makers withheld important information about the side effects and bleeding risks in comparison to warfarin, which has a well established reversal agent.
In this latest study, researchers from Denmark looked at data from more than 55,000 patients in the country’s national registries to weigh the benefits and risks of Pradaxa (dabigatran), Eliquis (apixaban), and Xarelto (rivaroxaban) when compared to warfarin.
After one year of follow up, 4.8% of Eliquis patients suffered either an ischemic stroke or systemic embolism, compared to only 3.3% of Pradaxa users, 3.5% of Xarelto users, and 3.7% of warfarin patients. As a result, researchers calculated that Eliquis side effects may involve a 20% increased risk of stroke or embolism when compared to the older drug.
Additionally, the findings indicated that the overall risk of death was higher among patients given Eliquis and Xarelto, with both drugs carrying about a 50% increased risk for all-cause mortality.
Researchers also found that all of the drugs carried similar bleeding risks, except for Pradaxa, which carried a lower risk than the others.
“[I]t might be important to review concerns about safety of oral anticoagulant treatment in atrial fibrillation: ineffective or insufficient treatment for stroke prevention should be viewed as a safety issue itself, while the increase in the risk of bleeding is an inevitable consequence of a necessary treatment,” the researchers determined. “Thus, choosing the appropriate antithrombotic agent for each individual is paramount to reduce the stroke burden in atrial fibrillation, while a relative increase in risk of bleeding cannot be ruled out.”
Blood Thinner Lawsuits
Safety concerns over the drugs have been thrust into the spotlight over the last two years, as they increase in popularity and use.
According to allegations raised in product liability lawsuits filed against the drug makers, the new generation anticoagulants never should have introduced before a safe and effective reversal agent was available, seeking damages for severe bleeds and wrongful deaths caused by problems on Xarelto, Pradaxa and Eliquis.
Following several years of litigation, Boehringer Ingelheim agreed to pay $650 million in Pradaxa settlements to resolve about 4,000 cases brought on behalf of individuals who suffered severe and sometimes fatal bleeds. However, the drug has recently gained a market advantage with the FDA approval of a reveral agent, marketing as Praxbind, which is designed to make the drug substantially safer.
A series of Xarelto bellwether trials, involving claims against Bayer and Janssen Pharmaceuticals, are expected to begin next year in the federal court system. While the outcomes of these trial dates are not binding on other claims in the litigation, they are designed to help parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, and may influence eventual Xarelto settlements to avoid the need for thousands of individual trials to be scheduled nationwide.
Meanwhile the Eliquis litigation has recently begun to grow amid concerns about this newest member of novel oral anticoagulant class, with consolidated pretrial proceedings recently established in the federal court system earlier this month, centralizing cases nationwide before U.S. District Judge Denise L. Cole in the Southern District of New York.