The publication reported that Janssen failed to inform the FDA about the INRatio blood testing device, which was an important component of the ROCKET AF trial that eventually helped lead to the FDA approving Xarelto in 2011.
The ROCKET AF trial compared rivaroxaban (the generic name for Xarelto) to an older anti-coagulant, warfarin, to examine how effective each drug was at preventing strokes in patients who have non-valvular atrial fibrillation, or irregular heartbeat. The study showed that Xarelto and warfarin were equally effective in stroke prevention, but Xarelto resulted in fewer bleeding events – both of these were major findings that helped convince the FDA to approve Xarelto.
But the INRatio device, according to the report, provided inaccurate results – and neither Janssen nor Johnson & Johnson informed the FDA about these inaccuracies. The INRatio measures how quickly the blood coagulates (clots) in people taking warfarin, Xarelto and other blood-thinning medications. According to the BMJ, trial participants taking warfarin and using the INRatio were led to believe their blood-clotting levels were lower than they actually were. As a result, their doctors prescribed higher doses of warfarin. This could help to explain why warfarin caused more bleeding events than Xarelto in the ROCKET AF trial.
Thomas Marciniak, a former FDA official quoted in the BMJ report, said that the information submitted to the agency was “worthless” due to substantial inaccuracies. Marciniak was one of the drug reviewers on Janssen’s original application for Xarelto approval.
More than 10,000 people have filed lawsuits against both Johnson & Johnson and Bayer, the makers of Xarelto. They claim the companies failed to inform the public and healthcare providers about the risks of uncontrollable bleeding when taking the drug. While there is an antidote for a bleeding event for people taking another blood thinning drug known as warfarin, there is no such antidote for Xarelto.