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Xarelto has Higher Bleeding Risk Compared to Pradaxa Study Suggests

Oct 4, 2016

A study published online in the journal JAMA Internal Medicine found that patients taking Xarelto had a slightly higher risk of bleeding compared to patients taking Pradaxa. Both of these medications are new generation blood thinners used to reduce the risk of life-threatening blood clots in patients with atrial fibrillation, an abnormal heart rhythm. These drugs have emerged as a replacement for the decades-old warfarin.

Warfarin is difficult to monitor, which is why patients taking this anticoagulant need to undergo regular blood monitoring. Additionally, consuming certain foods and beverages may make warfarin less effective. Xarelto and Pradaxa patients do not have to undergo blood monitoring, but other safety concerns have been raised. Until recently, there was no antidote to stop bleeding if it starts in patients. This essentially meant that bleeding in Xarelto and Pradaxa users was uncontrollable. If bleeding begins in a patient taking warfarin, the drug can be reversed with vitamin K.

The study was conducted by researchers at the U.S. Food and Drug Administration (FDA), who said that it is unclear whether Pradaxa or Xarelto is safer. Dr. Rita Redberg, a professor of cardiology at the University of California, San Francisco who had no role in the study, said "There are now several new oral anticoagulants and we don't have a lot of studies that compare one to the other," according to HealthDay. "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 said the study found that Xarelto was linked to a "slight increased risk of bleeding," compared to Pradaxa. In noting the lack of an antidote for these drugs, she said "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," Recently, an antidote for Pradaxa was approved.

The study gathered data on 119,000 Medicare patients with atrial fibrillation treated with either Xarelto or Pradaxa from November 2011 through June 2014. There was no significant difference in stroke risk between the two drugs. Patients taking Xarelto had a slightly higher risk of bleeding in the brain and stomach; the difference was small but statistically significant. Xarelto was also associated with a small but statistically significant increased risk of death in certain patients ages 75 years and older.

The findings do not indicate a cause-and-effect relationship; it only shows an association. Furthermore, the study was limited by the fact that patients were already taking either Xarelto or Pradaxa when the study started. The drugs were not randomly assigned.

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