A Medwatch review of reported events in patients who discontinued rivaroxaban (XARELTO) therapy in response to legal advertising

Introduction Rivaroxaban (XARELTO) is an oral Factor Xa inhibitor anticoagulant. Studied in over 85,000 patients, it was initially approved by the FDA in 2011 and is indicated to treat or prevent thrombosis in a variety of clinical settings; and when appropriately prescribed, for example in patients with atrial fibrillation, rivaroxaban has similar anticoagulant efficacy, with a lower risk of intracranial hemorrhage, as compared to the historical standard of warfarin. It is well established that anticoagulant therapy is associated with an increased risk of hemorrhage, regardless of the specific anticoagulant. Therefore, in the risk–benefit balance, an appropriate anticoagulation prescription occurs in the setting of increased thrombotic risk that justifies the increased bleeding risk. This is an important consideration, as the mitigation of the thrombotic risk attained by the use of an anticoagulant is terminated if the anticoagulant is stopped. Importantly, current evidence does not suggest a rebound of thrombotic risk upon anticoagulation discontinuation; rather, the patient simply resumes the thrombotic risk that existed prior to anticoagulant initiation, and the lack of rebound thrombosis with rivaroxaban is supported by longitudinal studies. However, in a patient at risk for a thrombotic event, premature discontinuation of any oral anticoagulant may increase the risk of thrombotic events, as outlined in The United States Prescribing Information for all of the newer non-warfarin anticoagulants (https://www. xarelto-us.com/shared/product/xarelto/prescribing-informa tion.pdf; http://packageinserts.bms.com/pi/pi_eliquis.pdf;