Researchers looked at data on 27,467 patients who used Xarelto. From January 2013 to March 2014, there were 496 major bleeding events in 478 patients, which translates to 2.86 incidents per 100 person-years.
There were also 14 deaths from major bleeding during the study, which translates to a fatal bleeding rate of 0.08 per 100 person-years.
The study was funded by Janssen and Bayer HealthCare, the manufacturers of Xarelto. It was conducted by researchers from Baylor College of Medicine and other medical organizations.
Janssen reported that rates of major bleeding in clinical practice were overall consistent with those seen in ROCKET-AF, a Phase III clinical trial that was used to approve Xarelto. The researchers said the study supports the safety profile of Xarelto, but they did note that older patients (average age 78) experienced more bleeding.
Janssen and Bayer are facing about 80 lawsuits in federal court on behalf of people who were severely injured by bleeding after taking Xarelto. Lawsuits accuse the drug-makers of failing to adequately warn about the risk of severe, sometimes fatal bleeding from Xarelto.
Although bleeding is one of the most well-known side effects of blood-thinners, Xarelto was released in 2011 without an effective reversal agent — unlike warfarin, its main competitor, which can be reversed with a dose of Vitamin K. Fortunately, in the last few months a small pharmaceutical company has announced that they are testing a possible antidote.
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