Eliquis Adherence Not Affected By Patient Education: Study

Patients taking the controversial anticoagulant Eliquis may be more likely to take the drug dutifully, regardless of whether they are educated about its benefits and potential side effects, according to the findings of new research. 

In a study presented on Sunday at a conference by the European Society of Cardiology in London, French researchers evaluated patient adherence to Eliquis, which is a part of a new-generation of blood thinners introduced in recent years as a replacement for Coumadin (warfarin).

Researchers found that after about six months, nearly 90% of Eliquis users were still taking the pill as directed. The study has not yet been published or peer-reviewed.

As part of the study, Eliquis patients were placed into two groups, based on whether they underwent an adherence education program or not, and researchers tracked their use of the drug for six months. Regardless of which group they were in, about 88.3% of the study’s participants were still taking Eliquis as prescribed at the end of the six months.

Sponsored by the drug’s manufacturer, Bristol-Myers Squibb, the study is being touted as another advantage for the new anticoagulant over wafarin, which has been the go-to treatment for decades for the prevention of strokes among patients with atrial fibrillation. Eliquis is promoted as easier to use, with the drug makers maintaining that it requires less monitoring than warfarin. Similar claims have been raised by the makers of other new-generation anticoagulants introduced in recent years, including Pradaxa and Xarelto.

Amid the aggressive promotion of this new class of anticoagulants, sales for Eliquis, Xarelto and Pradaxa have risen sharply in recent years. However, concerns have also emerged about potential bleeding side effects, as each of the drugs were introduced without a safe and effective reversal agent, resulting in many users suffering severe and sometimes fatal injuries due to uncontrollable bleeding.

New Blood Thinner Concerns

Pradaxa was the first member of this new generation of blood thinners to hit the market, introduced by Boehringer Ingelheim in October 2012. Xarelto was the second member, introduced by Bayer and Janssen Pharmaceuticals in 2011. Bristol-Myers Squibb introduced Eliquis in 2012.

While all blood thinners carry a risk of bleeding, Eliquis, Pradaxa and Xarelto have all been linked to a large number of incidents involving uncontrollable hemorrhaging that doctors were unable to stop.

Unlike warfarin, which has an effective antidote available that doctors can use to counteract the blood thinning effects of the drug, there are no approved reversal agents for Eliquis, Pradaxa or Xarelto. As a result, many doctors have reported being unable to control or stop bleeding problems that develop among users of of these new drugs, potentially increasing the risk of severe injury or death.

Thousands of Pradaxa lawsuits, Xarelto lawsuits and Eliquis lawsuits have been filed by users of these medications, alleging that the drug makers placed their desire for profits before patient safety by failing to adequately warn about the bleeding risk and the lack of an effective reversal agent.

Following several years of litigation, Boehringer Ingelheim agreed to pay about $650 million in Pradaxa settlements in May 2014, to resolve about 4,000 cases, with an average of about $150,000 awarded to former users who experienced severe and sometimes fatal bleeds. However, additional cases continue to be brought by individuals who experienced bleeds.

More than 1,200 lawsuits over Xarelto side effects are now pending throughout the federal court system, where the litigation has been centralized before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana for coordinated pretrial proceedings.

A small group of Xarelto cases are being prepared for early trial dates next year, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be offered throughout the litigation. Known as “bellwether” cases, if the drug makers fail to reach Xarelto settlements or another resolution for the cases following these early trials, they could face individual trial dates in courts throughout the U.S.

In recent weeks, a growing number of lawsuits over Eliquis bleeding problems have also been filed, raising nearly identical allegations over this most recent addition to the class of anticoagulants.