Evaluation of Rivaroxaban- and Dabigatran-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database  (FAERS)

Background Rivaroxaban and dabigatran are non-vitamin K antagonist oral anticoagulants that are widely used for treatment and prevention of venous thrombo-embolism and prevention of stroke in patients with atrial fibrillation. Objective To estimate and compare hemorrhagic events reported for rivaroxaban and dabigatran. Setting FDA Adverse Event Reporting System (FAERS) database. Methods The reporting odds ratio (ROR) was used to analyze the reporting of hemorrhagic events. Main outcome measure The overall hemorrhagic events and hemorrhagic events in different physiological systems and indications. Results A total of 53,085 reports of hemorrhage related to rivaroxaban, accounting for 49.79% of all rivaroxaban-related ADR reports and 13151 hemorrhagic reports related to dabigatran, accounting for 38.51% of all dabigatran-related ADR reports. The overall ROR (95% CI) for hemorrhagic event reporting for rivaroxaban compared with dabigatran was 1.58 (95% CI 1.54-1.62). The RORs (95% CI) in gastrointestinal systems, nervous system, renal and urinary system, skin and subcutaneous tissue, and eye system were 1.38 (1.34-1.42), 0.94 (0.90-0.98), 1.07 (1.01-1.13), 0.80 (0.70-0.90), and 1.38 (1.19-1.60), respectively. The RORs (95% CI) for hemorrhagic events in patients with atrial fibrillation, pulmonary embolism and deep vein thrombosis comparing rivaroxaban with dabigatran were 1.85 (1.79-1.91), 2.02 (1.67-2.47) and 2.17 (1.82-2.59). Conclusions Overall, a moderate signal for hemorrhage associated with rivaroxaban use was observed when compared with dabigatran. Hemorrhagic events in different physiological systems were not have a higher risk in case reports of rivaroxaban compared to dabigatran. But for the treatment of patients with pulmonary embolism or deep vein thrombosis, rivaroxaban are associated with more hemorrhagic events compared to dabigatran.