OBJECTIVES: To investigate the risk of bleeding events associated with concurrent administration of dabigatran-dronedarone compared with dabigatran standalone therapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and to identify the characteristics of patients with bleeding events associated with concurrent use of dabigatran and dronedarone. DESIGN: Retrospective data mining analysis. SETTING: United States, from the dabigatran approval date (October 19, 2010) through the fourth quarter of 2011. PATIENTS: Cases from FAERS with bleeding events (combined in a single term based on adverse event reports such as hemorrhage and rectal hemorrhage) as the adverse event. INTERVENTION: Cases listing concomitant use of the terms Pradaxa, dabigatran, or dabigatran etexilate with Multaq or dronedarone as the suspect drug from FAERS and cases listing dabigatran and dronedarone as standalone therapies were extracted for analysis. MAIN OUTCOME MEASURE: Risk of bleeding among those using dabigatran-dronedarone concomitantly compared with those using dabigatran standalone therapy. RESULTS: 108 dabigatran-dronedarone interaction reports and 14,913 reports concerning bleeding events were extracted from FAERS. Of 108 dabigatran-dronedarone interaction cases, 51 were associated with bleeding events. The odds ratio (OR) for risk of bleeding in patients using dabigatran and dronedarone concomitantly compared with those using neither of the suspect drugs was 13.80 (95% CI 9.45-20.14). The OR for risk of bleeding in patients using only dabigatran compared with those using neither of the suspect drugs was 16.06 (15.00-17.19). CONCLUSION: The likelihood of reporting bleeding events to FAERS among patients using dabigatran only was similar to that among patients using dabigatran and dronedarone concomitantly.
OBJECTIVES: To investigate the risk of bleeding events associated with concurrent administration of dabigatran-dronedarone compared with dabigatran standalone therapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and to identify the characteristics of patients with bleeding events associated with concurrent use of dabigatran and dronedarone. DESIGN: Retrospective data mining analysis. SETTING: United States, from the dabigatran approval date (October 19, 2010) through the fourth quarter of 2011. PATIENTS: Cases from FAERS with bleeding events (combined in a single term based on adverse event reports such as hemorrhage and rectal hemorrhage) as the adverse event. INTERVENTION: Cases listing concomitant use of the terms Pradaxa, dabigatran, or dabigatran etexilate with Multaq or dronedarone as the suspect drug from FAERS and cases listing dabigatran and dronedarone as standalone therapies were extracted for analysis. MAIN OUTCOME MEASURE: Risk of bleeding among those using dabigatran-dronedarone concomitantly compared with those using dabigatran standalone therapy. RESULTS: 108 dabigatran-dronedarone interaction reports and 14,913 reports concerning bleeding events were extracted from FAERS. Of 108 dabigatran-dronedarone interaction cases, 51 were associated with bleeding events. The odds ratio (OR) for risk of bleeding in patients using dabigatran and dronedarone concomitantly compared with those using neither of the suspect drugs was 13.80 (95% CI 9.45-20.14). The OR for risk of bleeding in patients using only dabigatran compared with those using neither of the suspect drugs was 16.06 (15.00-17.19). CONCLUSION: The likelihood of reporting bleeding events to FAERS among patients using dabigatran only was similar to that among patients using dabigatran and dronedarone concomitantly.