Zhou Yan, Lu Yun, Wu Yu, Kong Wenqiang, Zhou Lu, Guo Xirui, Wei Hua, Wang Hongju, Xie Fangqing, Yan Shihao, Yang Fang, Liu Chun, Li Qinchuan, Li Na, Zou Ya, Chen Jia
Department of Pharmacy, Chengdu Second People' s Hospital, Chengdu, Sichuan, China.
Department of Pharmacy, Zigong First People's Hospital, Zigong, Sichuan, China.
PLoS One. 2025 Aug 13;20(8):e0330025. doi: 10.1371/journal.pone.0330025. eCollection 2025.
BACKGROUND: Depression is a common mental disorder in children and adolescents, and antidepressants are widely used for treatment. This study aimed to explore and analyze adverse events (AEs) associated with antidepressant use in this population, providing insights for safety assessment. METHODS: This study extracted AE reports from the US FDA Adverse Event Reporting System (FAERS) for children and adolescents aged 6-17 years from 2014-2023, with fluoxetine, escitalopram, and sertraline as the primary suspected drugs. The study used the International Dictionary of Medical Terminology (MedDRA) to encode and classify AEs, and employed the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods for data mining. RESULTS: The FAERS database included 9,845 AE reports involving fluoxetine, escitalopram, and sertraline among children and adolescents aged 6-17 years. After removing duplicates, the analysis yielded 1,604, 352, and 571 AEs for fluoxetine, escitalopram, and sertraline, respectively. The study population demonstrated a sex distribution with approximately twice as many female patients as male patients, with most patients aged 12-17 years. At the system organ class (SOC) level, the AEs predominantly involved psychiatric disorders and nervous system disorders. Within the psychiatric disorders category at the high level group term (HLGT) level, the most frequently reported AE signals across all three medications were suicidal and self-injurious behaviors (not elsewhere classified, hereinafter referred to as NEC) and anxiety disorders and symptoms; For nervous system disorders, the predominant AE signals were neurological disorders (NEC) and movement disorders (including parkinsonism). At the Preferred Term (PT) level, the three antidepressants demonstrated similar AEs, including various suicidal and self-injurious behaviors, intentional overdose, neurological disorders (including serotonin syndrome, extravertebral reactions, etc) and prolonged QT. The typical AEs of fluoxetine included decreased appetite, insomnia, and urinary retention. Escitalopram was associated with additional AEs of sexual dysfunction and toxic epidermal necrolysis, whereas sertraline demonstrated unique associations with headache and rhabdomyolysis. CONCLUSION: This study may offer further evidence regarding AEs associated with commonly prescribed antidepressants in children and adolescents. Overall, the findings are mostly consistent with the AEs recorded in the packaging instructions and previous reports. However, the study also identified previously unreported AEs and highlighted variations in the AE profiles across different demographic groups. As the causal relationships between these medications and the observed AEs remain to be fully elucidated, additional research is warranted to confirm these findings.
背景:抑郁症是儿童和青少年常见的精神障碍,抗抑郁药被广泛用于治疗。本研究旨在探索和分析该人群使用抗抑郁药相关的不良事件(AE),为安全性评估提供见解。 方法:本研究从美国食品药品监督管理局不良事件报告系统(FAERS)中提取了2014年至2023年6至17岁儿童和青少年的AE报告,以氟西汀、艾司西酞普兰和舍曲林作为主要可疑药物。该研究使用国际医学术语词典(MedDRA)对AE进行编码和分类,并采用报告比值比(ROR)和比例报告比(PRR)方法进行数据挖掘。 结果:FAERS数据库包含9845份6至17岁儿童和青少年中涉及氟西汀、艾司西酞普兰和舍曲林的AE报告。去除重复报告后,分析分别得出氟西汀、艾司西酞普兰和舍曲林的AE有1604例、352例和571例。研究人群的性别分布显示女性患者约为男性患者的两倍,大多数患者年龄在12至17岁。在系统器官分类(SOC)层面,AE主要涉及精神障碍和神经系统障碍。在高级组术语(HLGT)层面的精神障碍类别中,所有三种药物最常报告的AE信号是自杀和自伤行为(未另作分类,以下简称NEC)以及焦虑症和症状;对于神经系统障碍,主要的AE信号是神经障碍(NEC)和运动障碍(包括帕金森症)。在首选术语(PT)层面,三种抗抑郁药表现出相似的AE,包括各种自杀和自伤行为、故意过量用药、神经障碍(包括血清素综合征、椎体外反应等)以及QT间期延长。氟西汀的典型AE包括食欲减退、失眠和尿潴留。艾司西酞普兰还与性功能障碍和中毒性表皮坏死松解症等额外的AE相关,而舍曲林则与头痛和横纹肌溶解症有独特关联。 结论:本研究可能为儿童和青少年常用抗抑郁药相关的AE提供进一步证据。总体而言,研究结果大多与包装说明书和先前报告中记录的AE一致。然而,该研究还发现了先前未报告的AE,并强调了不同人群AE特征的差异。由于这些药物与观察到的AE之间的因果关系仍有待充分阐明,因此需要进一步研究来证实这些发现。
Cochrane Database Syst Rev. 2021-5-24
Cochrane Database Syst Rev. 2012-11-14
Psychopharmacol Bull. 2024-7-8
Cochrane Database Syst Rev. 2023-10-9
Cochrane Database Syst Rev. 2014-9-11
Cochrane Database Syst Rev. 2023-11-28
J Pharm Policy Pract. 2024-7-29
Eur J Clin Pharmacol. 2024-2