Analysis of Duloxetine-Related Adverse Events Using the Food and Drug Administration Adverse Event Reporting System: Implications for Monitoring and Management.

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Journal of Clinical Psychopharmacology Pub Date : 2025-03-01 Epub Date: 2025-02-13 DOI:10.1097/JCP.0000000000001966
Meng Zhu, Shengxia Lv, Feiye Zhu, Yongsheng Zhang
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引用次数: 0

Abstract

Background: The objective of this study was to examine the characteristics of adverse drug reactions of duloxetine and investigate the potential precautions that may exist beyond the drug label.

Methods: This study used data from the Food and Drug Administration Adverse Event Reporting System database 2004-2023 and the linked information of duloxetine. Four algorithms used to evaluate the correlation between duloxetine and adverse events include reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.

Results: Adverse reactions involving duloxetine were associated with 24 System Organ Classes. Among them, the three most frequent systems affected were psychiatric disorders (reporting odds ratio [ROR] 5.05), nervous system disorders (ROR 2.27), and general medical conditions and administration site conditions (ROR 0.83). Of particular note, the number of reported cases and the risk of occurrence of adverse events of drug withdrawal syndrome (n = 7498), nausea (n = 7942), and headache (n = 5732) were the highest, increasing each year and reached a peak submission in 2017. More importantly, the occurrence of reproductive system and breast disorders (chisq 317.85) was not mentioned in the drug leaflet.

Conclusions: Psychiatric and nervous system disorders are the most frequently reported adverse events associated with duloxetine, with drug withdrawal syndrome, nausea, and headache being especially common. The emergence of mood-related symptoms, such as agitation and irritability, underscores the need for vigilant monitoring of mental health. Additionally, potential risks affecting the reproductive system suggest areas for further attention. These findings highlight the importance of proactive monitoring to improve patient safety during duloxetine treatment.

使用食品和药物管理局不良事件报告系统分析度洛西汀相关不良事件:对监测和管理的影响。
背景:本研究的目的是研究度洛西汀的药物不良反应的特点,并探讨药物标签之外可能存在的潜在预防措施。方法:本研究使用2004-2023年美国食品药品监督管理局不良事件报告系统数据库中的数据和度洛西汀的相关信息。用于评价度洛西汀与不良事件相关性的四种算法包括报告优势比、比例报告比、贝叶斯置信传播神经网络和多项目伽玛泊松收缩器。结果:涉及度洛西汀的不良反应与24个系统器官分类相关。其中,最常受影响的三个系统是精神疾病(报告优势比[ROR] 5.05)、神经系统疾病(ROR 2.27)和一般医疗状况和给药部位状况(ROR 0.83)。值得注意的是,药物戒断综合征(n = 7498)、恶心(n = 7942)和头痛(n = 5732)的报告病例数和不良事件发生风险最高,且逐年增加,并在2017年达到高峰。更重要的是,药物说明书中没有提到生殖系统和乳房疾病(chisq 317.85)的发生。结论:精神和神经系统疾病是度洛西汀最常报道的不良事件,其中药物戒断综合征、恶心和头痛尤为常见。情绪相关症状的出现,如躁动和易怒,强调了对心理健康进行警惕监测的必要性。此外,影响生殖系统的潜在风险建议进一步关注的领域。这些发现强调了在度洛西汀治疗期间进行主动监测以提高患者安全性的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.00
自引率
3.40%
发文量
231
审稿时长
4-8 weeks
期刊介绍: Journal of Clinical Psychopharmacology, a leading publication in psychopharmacology, offers a wide range of articles reporting on clinical trials and studies, side effects, drug interactions, overdose management, pharmacogenetics, pharmacokinetics, and psychiatric effects of non-psychiatric drugs. The journal keeps clinician-scientists and trainees up-to-date on the latest clinical developments in psychopharmacologic agents, presenting the extensive coverage needed to keep up with every development in this fast-growing field.
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