Comparison of Safety Profiles for Dapagliflozin Based on Safety Issues of EMA and FDA: Challenges and Future of Post-Marketing Surveillance in Korea

Abstract

Abstract Europe, the United States, and Korea each have post-marketing surveillance (PMS) systems for rare or unexpected adverse events (AEs). To compare similarities in the PMS AEs from three regulatory agencies, we used information on the regulatory decisions for dapagliflozin. We examined the risk management plan of the European Medicines Agency (EMA) and the drug label of the Food and Drug Administration (FDA). In Korea, we utilized the outcomes of the signal detection we conducted using the Korea Adverse Event Reporting System (KAERS) data and the results of the use-result surveillance listed on the drug labels. Based on the safety issues of EMA and FDA, signals from KAERS and AEs from the use-result surveillance were manually matched and compared. We compared 38 signals from KAERS and 231 AEs from the use-result surveillance data based on 17 safety issues identified by EMA and FDA. We found that 71% of these safety issues were consistent with those in Korea. However, bladder carcinoma, haematocrit increased, hypoglycaemia, low-density lipoprotein increased, and prostate cancer were not identified in Korea. The EMA and FDA have implemented ongoing PMS systems to identify and address long-term AEs. Korea needs to develop processes for strengthening and evaluating signals.