Efficacy of Single-Dose Xarelto Questioned

Xarelto burst upon the market promoted as a more convenient alternative to warfarin, the leading blood-thinner, used to reduce the risk of blood clots following knee or hip joint replacement surgery. Xarelto came in a single dose and, according to the manufacturer, did not require blood monitoring.

Roopal Luhana, writing for The Legal Examiner, issues a warning based on an editorial in the Journal of the American Medical Association (JAMA) that questions the wisdom of a one-size-fits-all dose of Xarelto. She points out that doctors who had put their patients on warfarin did so because they wanted to be sure the blood thinner they were prescribing was not thinning their patients’ blood too much. She wrote that this means that these patients would have been at risk for excessive bleeding.

She reported that, according to The Institute for Safe Medicine Practices, by 2013, the number of adverse bleeding events associated with Xarelto had overtaken those with Pradaxa (dabigatran—a similar blood thinner), with nearly 700 cases reported.

In the Journal of Cardiology researchers reported that of 136 patients who were taking Xarelto, 29 of them were found to have a reduced clotting time that was “significantly longer than baseline.”

Luhana reports that J. Robert Powell, PharmD, published an editorial in JAMA questioning the dosage recommendations for Xarelto. He wrote, “The ability to understand how to optimally achieve anticoagulation with warfarin took 60 years since its approval by the U.S. Food and Drug Administration in 1954.”

According to Luhana, Powell goes on to state that while the newer drugs come in one dose, supposedly without need for monitoring, such “convenience” may sacrifice patient safety, and may have a lot more to do with marketing and sales then what’s actually best for patients. Powell believes that manufacturers should come up with new dosing commendations that would better protect patients from dangerous bleeding side effects.