Detecting Drug Interaction Signal of Concomitant Use of Warfarin and Statins Using Korea Adverse Event Reporting System Database

Abstract

The increase in polypharmacy in elderly patients is recognized as a serious health, economic, and social problem. Warfarin and statins are commonly co-administered to cardiovascular disease patients. However, there is a potential risk of drug-drug interaction (DDI). The objective of this study was to detect signals of adverse events (AEs) for DDI after concomitant use of warfarin and statins using Korea adverse events reporting system (KAERS) database. KAERS database from January 2016 to December 2020 was used. Omega (Ω) shrinkage measure model and Chi-square statistics model were used to calculate the criteria for detecting AEs signal resulting from concomitant use of warfarin and statins. Three indices were used to define signals: Ω025 (frequentist) >0, Ω025 (Bayesian) >0, and >2. Detected signals were compared with AEs listed on the drug label in Korea, Micromedex, and SIDER for warfarin and statins, respectively. Twenty-seven AEs on reports of concomitant use were detected as signals. Of 27 detected signals, 11 signals, including breath odour not otherwise specified (NOS), depersonalization, gastrointestinal neoplasm NOS, pleural effusion, medical device complication, menopausal symptoms, oedema cerebral, osteitis, prostatic hyperplasia, lipoma, and skin hypertrophy, were not listed on drug label. We identified signals for concomitant use of warfarin and statins. Careful monitoring and further pharmacoepidemiological studies of DDI associated with new signals using other databases are needed.