Trepidations have been brought up that a medical device used in Xarelto’s clinical trial was defective, which may have influenced test results as more Xarelto lawsuits are added to the multidistrict litigation. Although Janssen Pharmaceuticals and the study’s authors maintain the study’s conclusions are accurate, their critics demand for an investigation to be done.
ROCKET-AF trial (Rivaroxaban Once Daily Oral Direct Factor XA Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) which was published in 2011 in the New England Journal of Medicine, is the study in question. That study discovered that both rivaroxaban (the generic version of Xarelto) and warfarin – the older-generation anticoagulant – each lessened the risk of systemic embolism or ischemic stroke. The study also found no substantial difference between warfarin and rivaroxaban in the risk of a major bleeding event, but found rivaroxaban was linked with a lower risk of bleeding in the brain and fatal bleeding.
Janssen and Bayer Pharmaceuticals banked only on ROCKET-AF when it applied for approval from the FDA and European regulators according to editors at The BMJ (2/3/16). The study utilised a device known as an INRatio Monitor System, which measures the period it takes for blood to clot and which was recalled in December 2014 due to “clinically considerably lower” test results than patients might see in laboratory testing.
“In terms of the trial results, it could make rivaroxaban seem safer than it was in terms of the risk of bleeding and throws doubt on outcomes used to support the use of the world’s bestselling new oral anticoagulant,” Deborah Cohen writes in The BMJ “A falsely low reading could mean that patients had their warfarin dose unnecessarily increased, leading to a great risk of bleeding.”
Various critics have asked for an independent investigation of the ROCKET-AF trial, to find out whether the results were lopsided by the faulty device. The BMJ claims the FDAhas promised to review relevant data. However, the makers of the recalled device claim their own analysis confirmed the results of the study.
According to reliable reports, the study’s authors studied data and discovered that the likely device’s malfunction “did not have any substantial clinical effect on the major efficacy and safety results in the trial.” The European Medicines Agency is also quoted to have said that the recalled device did not influence the ROCKET-AF trial results.
There were 2,826 lawsuits consolidated for pretrial proceedings in MDL-2592, In Re: Xarelto (Rivaroxaban) Products Liability Litigation before US District Judge Eldon E. Fallon as of January 15, 2016.