The conclusions of the study were based on a large database of commercially insured adults in the United States between October 2010 and March 2012. The study included nearly 50,000 patients, including 1,649 on Xarelto and nearly 40,000 on warfarin.
After controlling for confounding variables, researchers concluded:
“Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out … a more than twofold higher risk of bleeding with [Xarelto] compared with warfarin.”
This is not the first time Xarelto has been linked to higher rates of gastrointestinal bleeding. Another study published in Gastroenterology found that patients on Xarelto were 50% more likely to have gastrointestinal bleeding.
Studies like these raise concerns about the “one-size-fits-all” dosing of Xarelto. Hundreds of lawsuits have been filed by people who accuse Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer of failing to adequately warn about severe, life-threatening bleeding before marketing Xarelto as an alternative to warfarin.
Unlike warfarin, which can be de-activated with a simple dose of Vitamin K, Xarelto has no reversal agent. In a bleeding emergency, patients on Xarelto are at risk of bleeding to death if the doctor cannot reverse its blood-thinning effects.
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