A study funded by Bayer HealthCare and Janssen Pharmaceuticals, the manufacturers of Xarelto, found that its rate of major bleeding is consistent with rates seen in clinical trials that led to Xarelto’s U.S. Food and Drug Administration (FDA) approval.

The study was published in Clinical Cardiology by researchers from Baylor College of Medicine in Texas and involved 27,467 people who used Xarelto at some point between Jan. 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 Xarelto 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 clinical trials, which was the cornerstone safety study the FDA used to approve Xarelto in 2011.

This new information comes on the heels of a study published in the Canadian Journal of Cardiology that determined Xarelto was no safer than Warfarin when it came to bleeding events.

What is Xarelto?

Xarelto is one of the newest blood thinners developed by Bayer and Janssen Pharmaceuticals. Blood thinners prevent dangerous blood clots that can obstruct the blood flow to the vital organs. Unlike older anticoagulants like Warfarin that require doctors to prescribe specific doses for each individual, Xarelto is prescribed in one uniform dose.

The FDA approved Xarelto for use in patients who have had knee or hip replacement surgery to reduce the risk of blood clots, reducing the risk of stroke in people with atrial fibrillation. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary bleeding.

Xarelto Side Effects

One of the most severe side effects of Xarelto is uncontrolled bleeding. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system.

While all blood thinners carry the risk of internal bleeding, older drugs like Warfarin have emergency antidotes to prevent serious harm. Xarelto does not have an antidote, and the drug cannot be flushed out of the system through dialysis. People who suffer bleeding can end up hospitalized, and the bleed may be fatal.

Xarelto Bleeding Lawsuits

A growing number of Xarelto lawsuits have been brought by injured patients and their surviving relatives who accuse the drug makers of putting their financial bottom line ahead of consumer safety by touting Xarelto as a safer blood thinner that does not require monitoring.

Bayer and Janssen are facing over 80 lawsuits involving people who were seriously injured or died from major bleeding after taking Xarelto. The Xarelto lawsuits allege that users of the drug were not adequately warned about the risk of severe, potentially fatal bleeding, or Xarelto’s lack of an effective reversal agent.