Xarelto Bleeding Rates Higher Than Low-Dose Aspirin in Stroke Study, Leading to Halt of Clinical Trial

A clinical trial designed to evaluate whether the controversial anticoagulant Xarelto may be used to prevent stroke and embolism has been halted, after the bleeding rates with Xarelto were higher than low-dose aspirin, and the drug appeared to be performing no better that the current treatment standard. 

Xarelto (rivaroxaban) is marketed jointly by Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, which announced the cancellation of the failed phase III study in a press release issued on October 5.

The drug makers cited efficacy and safety reasons for the decision, indicating that researchers decided that the study, known as NAVIGATE ESUS, would be unlikely to show any benefits to taking Xarelto over aspirin for embolic stroke if it were completed.

“This decision is based on the recommendation of the study’s Independent Data Monitoring Committee (IDMC) as the trial showed comparable efficacy between rivaroxaban and the standard of care, aspirin, and little chance of rivaroxaban showing an overall benefit versus aspirin if the study were to be completed,” the press release states. “While bleeding rates were very low overall and within the expected range, an increase in bleeding was observed in the rivaroxaban arm compared to aspirin.”

The study involved about 7,200 patients enrolled in 459 sites in 31 countries. Researchers were comparing stroke and systemic embolism rates among patients given either 15mg of Xarelto once per day or 100 mg of aspirin.

Researchers found that Xarelto had about the same effectiveness at preventing those strokes as aspirin, but carried a higher bleeding risk.

Xarelto Bleeding Lawsuits

The decision to halt this study over the Xarelto bleeding rates comes as the drug makers face more than 18,000 product liability lawsuits filed over severe and often fatal problems with uncontrollable bleeding while using the medication.

According to allegations raised in the pending Xarelto lawsuits, the drug makers failed to adequately research the medication before marketing it as a superior alternative to warfarin for individuals at risk of suffering a pulmonary embolism or other blood clot.

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 allege that Bayer and Johnson & Johnson failed to adequately warn users and the medical community about the lack of an antidote, which led to severe and uncontrollable bleeds.

Similar allegations were raised in thousands of Pradaxa lawsuits filed several years ago, as that other new-generation anticoagulant hit the market before Xarelto. However, the maker of that competing drug ultimately agreed to pay $650 million in Pradaxa settlements just before the first bellwether trials were set to begin, 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.