October 3, 2016 — The blood-thinning drug Xarelto was linked to a much higher risk of bleeding compared to Pradaxa in a new study by researchers at the FDA.
Xarelto slightly reduced the risk of stroke, but the benefit was not statistically significant and it was offset by a much higher risk of bleeding in the brain — 65% more patients on Xarelto experienced intracranial hemorrhage compared to Pradaxa.
Overall, 48% more patients on Xarelto experienced severe bleeding than patients on Pradaxa, mostly due to a higher rate of gastrointestinal bleeding.
Xarelto was also associated with a significantly increased risk of death for patients over 75 years old who also had at least one other risk-factor for stroke — such as a previous stroke, high blood pressure, congestive heart failure, or diabetes.
The results of the study were based on data from 119,000 Medicare patients with atrial fibrillation, a common heart rhythm disorder that can cause strokes. Patients were prescribed either Pradaxa or Xarelto (20-mg/day) from November 2011 to June 2014.
The study was led by Dr. David Graham, associate director of science at the FDA, and published today in JAMA Internal Medicine.
The problem with Xarelto is that it does not currently have a reversal agent. In an emergency, doctors may struggle to de-activate Xarelto and reverse its blood-thinning effects to stop bleeding. The FDA approved a reversal agent to Pradaxa — Praxbind — in October 2015.