In 2012, Xarelto’s first full year on the market, a total of 2,081 new Xarelto-associated SAE reports were filed with the FDA. Of those reported events, 151 resulted in death, as compared to only 56 deaths associated with warfarin.
Xarelto’s manufacturers promoted the drug as the next generation of blood-thinning drugs to replace Warfarin (Coumadin), a long-established safe treatment for preventing stroke and systemic embolism. Warfarin has been in use for 60 years.
However, the clinical studies showed that Xarelto had a higher rate of bleeding than Warfarin without substantial improvement in patient outcome.
In addition, Xarelto’s manufacturers insisted the drug does not require regular blood testing that would determine if patients were at risk of severe bleeding
, making it more convenient to prescribe.
However, review of the adverse event reports from Xarelto show that the use of Xarelto without appropriate blood monitoring and dose adjustment can cause major, life-threatening bleeding events.