Safety profiles of methylphenidate, amphetamine, and atomoxetine: analysis of spontaneous reports submitted to the food and drug administration adverse event reporting system

作者：Wei Wei, Li Chen, Hui Zhou, Jinfeng Liu, Yue Zhang, Shiyu Feng, Yingtao Bai, Yan-En Leng, En Chang, Liang Huang · 发表于：Frontiers in Pharmacology · 年份：2023 · DOI：10.3389/fphar.2023.1208456 · 被引用次数：22 · 研究领域：Attention Deficit Hyperactivity Disorder、Pharmacovigilance and Adverse Drug Reactions、Pharmaceutical studies and practices

Background: Methylphenidate, atomoxetine, and Amphetamine are the three most commonly used medications approved by the United States Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD). However, a comprehensive analysis of their safety profiles across various age groups and genders in real-world contexts has yet to be conducted. In this study, a pharmacovigilance analysis was performed using the FDA Adverse Event Reporting System (FAERS) database to examine differences in adverse events between methylphenidate, atomoxetine, and Amphetamine. Methods: From January 2014 to September 2022, FAERS reports listing “Methylphenidate,” “Dexmethylphenidate,” “Atomoxetine,” “Amphetamine,” “Lisdexamfetamine,” “Dextroamphetamine,” and “Methamphetamine” as primary suspects were analyzed after removing duplicate reports. We used the standardized Medical Dictionary for Regulatory Activities (MedDRA) query generalized search for adverse events at the preferred term level based on case reports. After filtering duplicate reports, disproportionality analysis was used to detect safety signals according to the proportional reporting ratio (PRR). In order to delve into potential safety concerns, we undertook a two-step analysis of the data. Initially, the data was segmented based on age cohorts: 0–5 years, 6–12 years, 13–18 years, and individuals aged ≥19 years. Following this, after partitioning the data into males and females within the 0–18 year...