소아 자발적부작용보고자료를 이용한 메틸페니데이트와 아토목세틴의 실마리정보검색

Signal Detection of Methylphenidate and Atomoxetine for Pediatric Patients using the Korean Adverse Event Reports Database System

Abstract—INTRODUCTION Methylphenidate and atomoxetine are considered to be the first-line treatment for attention deficit hyperactivity disorder patients. This study was performed to detect signals of adverse drug events after methylphenidate or atomoxetine for pediatric patients using the Korea Adverse Events Reporting System (KAERS) database. METHOD Disproportionality analysis were used to perform the data mining for methylphenidate and atomoxetine separately using KAERS database between 2015 and 2019. Three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) were calculated to detect signals, and signals not listed in the drug label of Korea were identified. RESULTS Among 61,808 spontaneous AEs reports, 196 reports contained methylphenidate, and 80 reports contained atomoxetine. The most common AEs were anorexia and nausea for methylphenidate and somnolence and nausea for atomoxetine. Among 51 signals of methylphenidate, 13 AEs were not listed on the drug label. For atomoxetine, 13 AEs of 32 signals were not currently included in the drug label. CONCLUSION We detected new AE signals of methylphenidate and atomoxetine that were not listed on the drug labels of Korea. To evaluate the causal association of signals, well-designed pharmacoepidemiologic research is needed.