Novel Oral Anticoagulant Safety Examined in New Study

A new report indicates that while, overall, a new generation of blood thinners may prove more effective at reducing stroke in patients with atrial fibrillation, doctors need to pay special care to a patient’s age, kidney functions and other factors due to the risk of bleeding with Xarelto, Pradaxa, Eliquis and other similar anticogulants. 

The report was published by researchers from Loyola Medicine and Loyola University Chicago Stritch School of Medicine, in the latest issue of Current Treatment Options in Cardiovascular Medicine.

Known as a factor xa medications, Xarelto, Pradaxa and Eliquis have been introduced in recent years as replacements for warfarin, which has been the go-to anticoagulation treatment for individuals at risk of blood clots due to atrial fibrillation, or following hip or knee replacmeent surgery. Amid aggressive marketing by the drug makers, the new-generation treatments have rapidly become widely used, but concerns about the safety of the drugs has also emerged.

According to the findings, the medications appear to decrease the risk of stroke in atrial fibrillation patients and do so without dietary restrictions or frequent monitoring requirements. However, researchers suggest that among certain populations of patients, they may pose a particular bleeding risk.

Since the medications were introduced, thousands of adverse event reports have been filed with federal regulators involving severe and uncontrollable bleeding problems with Xarelto, Pradaxa and Eliquis.

While all anticoagulants carry a risk of bleeds, the blood thinning effects of warfarin can be quickly reversed in the event of a hemorrhage or bleed, allowing doctors to stop and control the problems. However, there were no reversal agents available for Pradaxa, Xarelto or Eliquis until recently.

Last year, a reversal agent for Pradaxa, Praxbind, was approved by the FDA, which will make the medication substantially safer. In addition, another reversal agent for Xarelto and Eliquis is under consideration for approval.

The report said that the novel oral anticoagulants are overall safer than warfarin, despite the need to take into account “age, renal function, bleeding risk, cardiovascular comorbidities, cost and drug interactions.”

However, many critics do not agree, and both Pradaxa and Xarelto have been subject to thousands of product liability lawsuits by individuals who say they suffered life-threatening bleeding events or lost loved ones due to uncontrollable bleeding that doctors were powerless to stop.

Blood Thinner Litigation

Johnson & Johnson and Bayer, the makers of Xarelto, face more than 4,500 Xarelto lawsuits filed in federal courts nationwide.

Since December 2014, the cases have been centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated pretrial proceedings, given the similar questions of fact and law.

Each of the lawsuits involved in the Xarelto MDL raise nearly identical allegations, indicating that users and the medical community were provided inadequate warnings about the problems with uncontrollable bleeding on Xarelto, and the fact that the anticoagulant lacked a safe and effective reversal agent to allow doctors to quickly stop the blood thinning effects of the drug.

Similar claims were raised in the litigation over Pradaxa, which was introduced in October 2010, one year before Xarelto hit the market.

More than 4,000 Pradaxa lawsuits were ultimately filed by users of that drug who suffered bleeding injuries. Following several years of litigation, the manufacturer of that medication ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.

As Xarelto bleeding lawyers continue to review potential cases for individuals prescribed the anticoagulant throughout the United States, the number of complaints has surpassed the number of claims involved in the Pradaxa litigation, as the drug has become more widely used in recent years.