The blood thinner Xarelto (rivaroxaban) may pose an even greater risk of serious bleeding in patients diagnosed with atrial fibrillation than patients who take Pradaxa (dabigatran), according to a recent study.
Most patients diagnosed with atrial fibrillation take a blood thinner to reduce risks of stroke. While blood thinners do help prevent stroke, they may also lead to uncontrollable, sometimes fatal, bleeding, the researchers said, wrote HealthDay News.
Xarelto and Pradaxa are replacing an older medication, warfarin (also known by the brand name, Coumadin). Warfarin is known for being very challenging to monitor.
According to the U.S. Food and Drug Administration (FDA) there is no proof as to which of the drugs is safest. “There are now several new oral anticoagulants and we don’t have a lot of studies that compare one to the other,” said Dr. Rita Redberg, a professor of cardiology at the University of California, San Francisco, who had no role in the study, HealthDay News reported. “As a patient, you are making a decision with your doctor on how these compare with warfarin, and which one is right for you,” Redberg added.
For the recent study, Xarelto seemed to reveal a “slight increased risk of bleeding,” Redberg said. Study findings were published online October 3 in the journal JAMA Internal Medicine.
Patients taking warfarin must undergo frequent blood tests to ensure they are receiving the appropriate dose, while there is no antidote for Xarelto and Pradaxa should a major bleed occur. “There have been deaths reported of people who have had trauma and were on one of these new anticoagulants, and they were not able to be reversed,” Redberg said of Xarelto and Pradaxa, according to HealthDay News.
For the study, researchers led by Dr. David Graham, associate director of science at the FDA’s Center for Drug Evaluation and Research, collected data on nearly 119,000 Medicare patients with atrial fibrillation who were treated with either Xarelto or Pradaxa from November 2011 through June 2014.
The researchers found a small difference in stroke risk among patients who had taken either Pradaxa or Xarelto. There was a small, but statistically significant increase in risk of bleeding in the brain and stomach of patients taking Xarelto. Among certain patients who were 75 years of age and older, Xarelto was associated with a small but statistically significant increased risk of death, according to HealthDay News.
The study did not prove that Xarelto caused bleeding or death, just that there was an association, according to HealthDay News. A cardiologist who was not connected to the study said the FDA researchers’ findings should be reproduced in a randomized trial.