The results of a clinical trial for the approval of Xarelto (rivaroxaban) are being questioned by the U.S. Food and Drug Administration (FDA) after it was revealed that a faulty blood testing device may have compromised the results. Xarelto, an anti-clotting drug has been on the market since 2011 as an alternative to warfarin (Coumadin), an anti-coagulant that has been in use for over 60 years, reports The New York Times.
Warfarin requires careful, frequent monitoring of a patient’s diet, drug regimen, with frequent blood tests. If there is too little of the blood-thinner, a patient could suffer a stroke; too much, there may be life-threatening bleeding, according to the Times. Xarelto has been advertised to be more convenient for the patient, but where warfarin has an antidote in case of internal bleeding, Xarelto has no known antidote. In the case of a Xarelto user, an internal bleeding event could be catastrophic. More FDA Questions Xarelto Approval due to Faulty Blood Monitors