Bayer Healthcare and Janssen Pharmaceuticals are facing a federal multidistrict litigation (MDL) over the anticoagulant Xarelto. Plaintiff in the litigation allege the drug caused bleeding injuries, and accuse the companies of failing to warn about these risks. More than 2,800 lawsuits have been centralized to the MDL.
Xarelto was approved in 2011 to reduce the risk of blood clot and stroke in patients with conditions such as atrial fibrillation, deep vein thrombosis, pulmonary embolism and patients who recently underwent hip or knee replacement surgeries. It was part of a new line of blood thinners, along with Pradaxa. Before these new generation of blood thinners hit the market, the standard treatment was warfarin, an older medication which requires regular blood monitoring and dietary restrictions.
Generally, there is some risk of bleeding with all blood thinners. Plaintiffs in the litigation, however, emphasize that unlike warfarin, there is no antidote to reverse the bleeding in Xarelto. The suits allege that the drug makers never warned them about the risk of uncontrollable bleeding.
Plaintiffs cite two studies to support their allegations. One study was published in JAMA Opthamology June 2015 and authored by Drs. Judy Hun and John Hwang. They noticed a higher rate of eye bleeding, or vitreous hemorrhages, among patients in their practice who switched from warfarin to Xarelto, prompting them to document these events. “In all cases, an acute vitreous hemorrhage occurred shortly after rivaroxaban (Xarelto) treatment was initiated.” they stated.
The suits also reference the findings of another study, published in the April 2015 issue of BMJ. Researchers studied a sample of 46,000 patients taking Xarelto, Pradaxa or warfarin. They found that, compared to warfarin, patients taking Xarelto had a higher risk of gastrointestinal bleeding.