Rivaroxaban, better known as Xarelto®, has been associated with hundreds of adverse events involving fatal and near-fatal hemorrhaging since it received FDA approval in 2011. Within three years of its arrival on pharmacy shelves, the number of injuries due to Xarelto’s side effects has surpassed those caused by rival medication Pradaxa (dabigitran). The problem, according to the FDA, was that test subjects spent less than 60% of the time at the optimal international normalized ratio (a measure of how long it takes to form a blood clot, used to determine the effectiveness of oral anticoagulant medications). That time was shorter than it had been in other studies comparing new-generation anticoagulants to warfarin, and thus did not adequately demonstrate Xarelto to be as effective as the older drug.
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