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KMID : 1022920210090020100
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Journal of Korean Academy of Social & Managed Care Pharmacy
2021 Volume.9 No. 2 p.100 ~ p.110
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Signal Detection of Methylphenidate and Atomoxetine for Pediatric Patients using the Korean Adverse Event Reports Database System
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Jang Eun-Ji
Ahn Ji-Hye
Yang Bo-Ram
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Abstract
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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.
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KEYWORD
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Methylphenidate, Atomoxetine, KAERS Database, Data Mining, Signal, Pharmacovigilance, Spontaneous adverse event reporting
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