Product News and Recalls

Xarelto: Higher Risk Same Reward?

xarelto may be no more beneficial than warfarin and be more dangerousOver 1,200 Xarelto lawsuits are pending in a multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana. Xarelto plaintiffs allege that the anticoagulant drug’s manufacturers, including Bayer HealthCare Pharmaceuticals and Johnson & Johnson’s Janssen Pharmaceutical, did not provide patients and doctors with adequate warning about Xarelto’s severe bleeding risks.

Approved by the U.S. Food and Drug Administration (FDA) in 2011 to help treat certain patients at risk for embolic events, one of Xarelto’s primary selling points has been its reported reduced risk of severe bleeding. Bayer and Janssen have touted Xarelto as a safer, more effective alternative to Warfarin, the decades-old oral anticoagulant treatment. But mounting evidence suggests Xarelto may be less safe than previously thought.

Medical experts have questioned the legitimacy of Xarelto’s entire approval process, citing violations at clinical trial sites. One of the drug’s premarket studies was so problematic that the FDA refused to factor its results into Xarelto’s approval process. Additionally, the Institute for Safe Medication Practices has noted a consistent upsurge in the number of serious adverse event reports concerning Xarelto, with over 3,000 filed during the last reporting period. More recently, a study by French scientists concluded that Xarelto may be no safer than Warfarin in terms of severe bleeding in elderly patients.

Patients who have filed Xarelto bleeding lawsuits also point out that Xarelto has no approved antidote in case of severe bleeding. Compare this with Warfarin, for which vitamin K infusions can be used in the event of bleeding. This lack of a reliable remedy combined with dubious advantages over Warfarin have placed Xarelto in the middle of a fast-growing multidistrict litigation.

Talk to your doctor about any health risks your medications may pose. If you or a loved one suffered severe bleeding after taking Xarelto, contact Lopez McHugh to discuss your case free of charge with a qualified Xarelto attorney. We can help determine whether a Xarelto lawsuit is right for you.