In a new-user cohort study of 118,891 patients, rivaroxaban (Xarelto) treatment was associated with greatly increased intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding.
In this observational study published in JAMA Internal Medicine, Xarelto use was associated with increased intracranial and major extracranial bleeding events compared with Pradaxa use.
Plaintiffs have filed 16,285 lawsuits in IN RE: Xarelto (Rivaroxaban) Products Liability Litigation, consolidated in MDL 2592 in Louisiana. As a bellwether trial is underway in federal court in New Orleans, the makers of Xarelto are facing $2.5 billion in potential liability from patients who suffered uncontrollable internal bleeding.
Xarelto and Pradaxa are non–vitamin K oral anticoagulants approved for stroke prevention in patients with nonvalvular atrial fibrillation (AF). There are no randomized head-to-head comparisons of these drugs for stroke, bleeding, or mortality outcomes.
German drug maker Boehringer Ingelheim settled 4,590 cases involving Pradaxa (Dabigatran) for a total of $650 million in May 2014. Patients and their families claimed that Boehringer failed to properly warn them that the drug, which is used to prevent blood clots, caused serious and sometimes fatal bleeding that could not easily be reversed.
The average case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.
The JAMA study compared risks of thromboembolic stroke, intracranial hemorrhage intracranial hemorrhage, major extracranial bleeding including major gastrointestinal bleeding, and mortality in patients with nonvalvular AF who initiated dabigatran (Pradaxa) or rivaroxaban treatment for stroke prevention.
The study found that treatment with Xarelto 20 mg once daily was associated with statistically significant increases in intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding, compared with Pradaxa 150 mg twice daily.
The researchers also noted that, in 2014, rivaroxaban was prescribed two to three times more often than Pradaxa for AFib patients in the U.S., and they said that may be due to doctors falsely believing that Xarelto posed less risk of major bleeding events than Pradaxa.
The lawsuits stem from allegations that the anticoagulant Xarelto could cause uncontrollable bleeding in some people. They accuse the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — of failing to warn about Xarelto’s potential risks.
The first bellwether trial involves a Louisiana man with atrial fibrillation, who took Xarelto and suffered life-threatening gastrointestinal bleeding. Joseph Boudreaux Jr. took Xarelto for just under one month in 2014 before he was hospitalized for severe internal bleeding, according to the lawsuit. Boudreaux, Jr. et al v. Janssen Research & Development LLC et al (2:14-cv-02720)
He needed several blood transfusions and was hospitalized for five days as a result of his Xarelto bleeding episode. He then required follow-up medical treatment following his stay in the hospital.
Boudreaux filed a Xarelto lawsuit against Janssen and Bayer in December 2014, accusing the two manufacturers of concealing their knowledge of Xarelto’s defects from physicians and patients like himself.