Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin

Efe Eworuke (), Laura Hou, Rongmei Zhang, Hui-Lee Wong, Peter Waldron, Abby Anderson, Audrey Gassman, David Moeny and Ting-Ying Huang
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Efe Eworuke: U.S. Food and Drug Administration
Laura Hou: Harvard Pilgrim Health+ Care Institute
Rongmei Zhang: U.S. Food and Drug Administration
Hui-Lee Wong: U.S. Food and Drug Administration
Peter Waldron: U.S. Food and Drug Administration
Abby Anderson: Food and Drug Administration
Audrey Gassman: Food and Drug Administration
David Moeny: U.S. Food and Drug Administration
Ting-Ying Huang: Harvard Pilgrim Health+ Care Institute

Drug Safety, 2021, vol. 44, issue 7, No 4, 753-763

Abstract: Abstract Introduction There have been reports of clinically relevant uterine bleeding events among women of reproductive age exposed to rivaroxaban. Objective The aim of this study was to compare the risk of severe abnormal uterine bleeding (SAUB) resulting in transfusion or surgical intervention among women on rivaroxaban versus apixaban, dabigatran and warfarin. Methods We conducted a retrospective cohort study in the FDA’s Sentinel System (10/2010–09/2015) among females aged 18+ years with venous thromboembolism (VTE), or atrial flutter/fibrillation (AF) who newly initiated a direct oral anticoagulant (DOAC; rivaroxaban, apixaban, dabigatran) or warfarin. We followed women from dispensing date until the earliest of transfusion or surgery following vaginal bleeding, disenrollment, exposure or study end date, or recorded death. We estimated hazard ratios (HRs) using Cox proportional hazards regression via propensity score stratification. Four pairwise comparisons were conducted for each intervention. Results Overall, there was an increased risk of surgical intervention with rivaroxaban when compared with dabigatran (HR 1.19; 95% CI 1.03–1.38), apixaban (1.23; 1.04–1.47), and warfarin (1.34; 1.22–1.47). No difference in risk for surgical intervention was observed for dabigatran–apixaban comparisons. Increased risk of transfusion was observed for rivaroxaban compared with dabigatran (1.49; 1.03–2.17) only. For patients with no gynecological history, rivaroxaban was associated with risk of surgical intervention compared with dabigatran (1.22; 1.05–1.42), apixaban (1.25; 1.04–1.49), and warfarin (1.36; 1.23–1.50). Conclusion Our study found increased SAUB risk with rivaroxaban use compared with other DOACs or warfarin. Increased risk with rivaroxaban was present among women without underlying gynecological conditions. Women on anticoagulant therapy should be aware of a risk of SAUB.

Date: 2021
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DOI: 10.1007/s40264-021-01072-0

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