January 16, 2015 — A study funded by Bayer HealthCare and Janssen, the manufacturers of Xarelto, have found that its rate of major bleeding is consistent with rates seen in clinical trials.
The study was published in Clinical Cardiology by researchers from Baylor College of Medicine in Texas.
The study involved 27,467 people who used Xarelto at some point between January 1, 2013 and March 31, 2014.
During the study, there were 14 deaths caused by severe bleeding. Older adults (average age 78 years) were more likely to experience bleeding than younger patients.
Overall, the fatal bleeding rate was 0.08 per 100 person-years. There were 496 major bleeding events in 478 patients, for an overall rate of 2.86 incidents per 100 person-years.
Janssen concluded that the results of the study supported Xarelto’s safety profile. They were consistent with findings in the ROCKET-AF clinical trial, which was the cornerstone safety study the FDA used to approve Xarelto in 2011.
Bleeding is a well-known risk associated with all blood-thinning medications. However, Xarelto belongs to a new generation of blood-thinners that have no reversal agent (although recently a small pharmaceutical company announced they may have discovered an antidote).
Bayer and Janssen are facing approximately 80 lawsuits involving people who were seriously injured or died from major bleeding after taking Xarelto. Victims of this drug claim they were not adequately warned about the risk of severe, potentially fatal bleeding, or Xarelto’s lack of an effective reversal agent.