{"title":"与新型抗癫痫药物相关的精神疾病:FDA不良事件报告系统的现实世界歧化分析","authors":"Jiahao Li , Rujia Zhong , Feng Zhang , Yi Guo","doi":"10.1016/j.yebeh.2025.110722","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Antiseizure medications (ASMs), particularly newer agents such as levetiracetam, topiramate, and perampanel, are fundamental in treating epilepsy and related disorders. Our study aims to analyze the psychiatric safety profiles of newer ASMs.</div></div><div><h3>Research design and methods</h3><div>The data were extracted from the US FDA Adverse Event Reporting System (FAERS) database from 2004Q1 to 2024Q2. The analysis focused on the clinical characteristics, the ranking of adverse reactions, the time-to-onset, and the severity proportion of newer ASMs-related psychiatric disorders.</div></div><div><h3>Results</h3><div>Disproportionality analysis highlighted a significant association between newer ASMs and psychiatric adverse events (AEs), with drugs like perampanel and levetiracetam showing notably high risks for severe psychiatric outcomes such as aggression, suicidal ideation, and psychosis. The median time-to-onset of psychiatric AEs was 33 days, with a substantial proportion (46.4 %) occurring within the first 30 days of treatment. Among all ASMs, perampanel has the highest severe proportion of ASM-associated psychiatric disorders at 51.5 %.</div></div><div><h3>Conclusions</h3><div>Our findings underscore a significant link between the use of newer ASMs and the risk of developing psychiatric disorders, suggesting the need for careful psychiatric assessment and monitoring when prescribing these medications.</div></div>","PeriodicalId":11847,"journal":{"name":"Epilepsy & Behavior","volume":"172 ","pages":"Article 110722"},"PeriodicalIF":2.3000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Psychiatric disorders associated with newer antiseizure medications: A real-world disproportionality analysis of FDA adverse event reporting system\",\"authors\":\"Jiahao Li , Rujia Zhong , Feng Zhang , Yi Guo\",\"doi\":\"10.1016/j.yebeh.2025.110722\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Antiseizure medications (ASMs), particularly newer agents such as levetiracetam, topiramate, and perampanel, are fundamental in treating epilepsy and related disorders. Our study aims to analyze the psychiatric safety profiles of newer ASMs.</div></div><div><h3>Research design and methods</h3><div>The data were extracted from the US FDA Adverse Event Reporting System (FAERS) database from 2004Q1 to 2024Q2. The analysis focused on the clinical characteristics, the ranking of adverse reactions, the time-to-onset, and the severity proportion of newer ASMs-related psychiatric disorders.</div></div><div><h3>Results</h3><div>Disproportionality analysis highlighted a significant association between newer ASMs and psychiatric adverse events (AEs), with drugs like perampanel and levetiracetam showing notably high risks for severe psychiatric outcomes such as aggression, suicidal ideation, and psychosis. The median time-to-onset of psychiatric AEs was 33 days, with a substantial proportion (46.4 %) occurring within the first 30 days of treatment. Among all ASMs, perampanel has the highest severe proportion of ASM-associated psychiatric disorders at 51.5 %.</div></div><div><h3>Conclusions</h3><div>Our findings underscore a significant link between the use of newer ASMs and the risk of developing psychiatric disorders, suggesting the need for careful psychiatric assessment and monitoring when prescribing these medications.</div></div>\",\"PeriodicalId\":11847,\"journal\":{\"name\":\"Epilepsy & Behavior\",\"volume\":\"172 \",\"pages\":\"Article 110722\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-09-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Epilepsy & Behavior\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1525505025004627\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"BEHAVIORAL SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Epilepsy & Behavior","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1525505025004627","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"BEHAVIORAL SCIENCES","Score":null,"Total":0}
Psychiatric disorders associated with newer antiseizure medications: A real-world disproportionality analysis of FDA adverse event reporting system
Background
Antiseizure medications (ASMs), particularly newer agents such as levetiracetam, topiramate, and perampanel, are fundamental in treating epilepsy and related disorders. Our study aims to analyze the psychiatric safety profiles of newer ASMs.
Research design and methods
The data were extracted from the US FDA Adverse Event Reporting System (FAERS) database from 2004Q1 to 2024Q2. The analysis focused on the clinical characteristics, the ranking of adverse reactions, the time-to-onset, and the severity proportion of newer ASMs-related psychiatric disorders.
Results
Disproportionality analysis highlighted a significant association between newer ASMs and psychiatric adverse events (AEs), with drugs like perampanel and levetiracetam showing notably high risks for severe psychiatric outcomes such as aggression, suicidal ideation, and psychosis. The median time-to-onset of psychiatric AEs was 33 days, with a substantial proportion (46.4 %) occurring within the first 30 days of treatment. Among all ASMs, perampanel has the highest severe proportion of ASM-associated psychiatric disorders at 51.5 %.
Conclusions
Our findings underscore a significant link between the use of newer ASMs and the risk of developing psychiatric disorders, suggesting the need for careful psychiatric assessment and monitoring when prescribing these medications.
期刊介绍:
Epilepsy & Behavior is the fastest-growing international journal uniquely devoted to the rapid dissemination of the most current information available on the behavioral aspects of seizures and epilepsy.
Epilepsy & Behavior presents original peer-reviewed articles based on laboratory and clinical research. Topics are drawn from a variety of fields, including clinical neurology, neurosurgery, neuropsychiatry, neuropsychology, neurophysiology, neuropharmacology, and neuroimaging.
From September 2012 Epilepsy & Behavior stopped accepting Case Reports for publication in the journal. From this date authors who submit to Epilepsy & Behavior will be offered a transfer or asked to resubmit their Case Reports to its new sister journal, Epilepsy & Behavior Case Reports.