October 3, 2016 — Xarelto was associated with more severe bleeding than Pradaxa in a new study conducted by researchers at the FDA.
Xarelto slightly reduced the risk of stroke, but this benefit was offset by a significantly increased risk of bleeding in the brain. Patients on Xarelto were 65% more likely to have intracranial hemorrhage.
Xarelto was also associated with a 48% higher risk of severe bleeding vs. Pradaxa, mostly due to higher rates of gastrointestinal bleeding.
Compared to Pradaxa, Xarelto also significantly increased the risk of death for patients over 75 who also had at least one other risk-factor for stroke — high blood pressure, congestive heart failure, or diabetes.
The conclusions were based on data from 119,000 Medicare patients with atrial fibrillation who were given either Xarelto (20-mg once daily) or Pradaxa between November 2011 and June 2014.
The study was published in JAMA Internal Medicine by Dr. David Graham, associated director of science at the FDA.
Intracranial hemorrhage is an extremely serious risk in patients on Xarelto. There is no quick way to de-activate Xarelto in an emergency, so even minor bleeds can rapidly cause brain damage or death.
Xarelto and Pradaxa prevent blood clots and strokes by changing the chemistry of a patient’s blood. Until recently, neither had reversal agents. The FDA approved an antidote to Pradaxa in October 2015, but has not approved an antidote to Xarelto.
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