No New Concerns With Rivaroxaban, According to FDA Mini-Sentinel Assessment

The FDA analysis evaluated the safety of Xarelto in people with nonvalvular atrial fibrillation who initiated Xarelto or warfarin from November 2011 to April 2015.

Findings from the Food and Drug Administration (FDA)’s Mini-Sentinel assessment confirm the safety and efficacy of Xarelto (rivaroxaban; Janssen), as previously established in the ROCKET AF Phase 3 trials. The report also indicates a reduced risk of ischemic stroke associated with the use of Xarelto compared to warfarin; this relationship was sustained throughout the analysis, which lasted over 3 years. 

To assess safety, the FDA analysis included ICD-9-CM codes from inpatient claims to evaluate the rates of gastrointestinal (GI) bleeding, ischemic stroke, and intracranial hemorrhage in patients with nonvalvular atrial fibrillation (AF) who started therapy with rivaroxaban or warfarin from November 2011 to April 2015. The hazard ratios for rivaroxaban compared to warfarin new users were 0.61 (0.47–0.79) for ischemic stroke, 1.47 (1.29–1.67) for GI bleeding, and 0.71 (0.50–1.01) for intracranial hemorrhage.

Related Articles

In 2008, the Sentinel Initiative was launched to electronically monitor the safety of FDA-approved and regulated products using existing electronic healthcare data. The Mini-Sentinel was initiated as a pilot project to develop an active surveillance system and add to the existing strategies of safety surveillance. In its report, the FDA concludes this study, “demonstrates the capability of Sentinel to conduct prospective safety monitoring with sophisticated re-usable tools and does not raise any new safety concerns regarding use of rivaroxaban.”

Xarelto, a factor Xa inhibitor, is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF; to treat deep vein thrombosis (DVT), pulmonary embolism (PE); to reduce the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting ≥6 months; and as prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

Full findings were published in the journal Pharmacoepidemiology & Drug Safety.

For more information call (800) 526-7736 or visit