Adverse events associated with carbamazepine: a pharmacovigilance study using the FDA Adverse Event Reporting System.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-25 DOI:10.1080/14740338.2024.2416926
Shulan Huang, Hanlin Dong, Dongqiang Luo, Jiazhen Jiang, Manting Liu, Jiayu Wu, Xiangyun Dou, Siyuan Zhou
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Abstract

Introduction: Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation.

Areas covered: Using the FDA Adverse Event Reporting System (FAERS) database , we extracted reports where CBZ was the primary suspect, conducting subgroup analyses stratified by sex and age. Four risk signal detection methods ROR, PRR, BCPNN, and EGBM were employed to systematically analyze the ADRs associated with CBZ.

Expert opinion: In the epilepsy population, ADRs related to CBZ often involve examinations, hereditary disorders, and infections. Subgroup analysis showed differences in ADR signals among male, female, elderly, and young patients. Human Herpesvirus 6 Infection and Dermatitis Exfoliative were consistent CBZ-induced ADRs, unaffected by age or sex. The study also identified previously overlooked ADRs such as bone metabolism abnormalities, ocular toxicity, and ototoxicity. Many ADRs linked to CBZ remain underreported. It is crucial to enhance monitoring and information dissemination about CBZ use in epileptic patients. Adjusting medication regimens for high-risk individuals, potentially incorporating acupuncture, traditional Chinese medicine, or alternative anti-seizure medications, should be considered when necessary.

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与卡马西平相关的不良事件:使用美国食品药物管理局不良事件报告系统进行的药物警戒研究。
简介:卡马西平(CBZ)是一种常用的抗癫痫药物(ASM),但其药物不良反应(ADRs)会影响癫痫的成功治疗。目前关于 CBZ 相关药物不良反应的系统研究还很有限,因此有必要进行进一步调查:利用美国食品药物管理局不良事件报告系统(FAERS)数据库,我们提取了以 CBZ 为主要可疑药物的报告,并按性别和年龄进行了亚组分析。我们采用了四种风险信号检测方法 ROR、PRR、BCPNN 和 EGBM,对与 CBZ 相关的 ADR 进行了系统分析:在癫痫人群中,与CBZ相关的ADR通常涉及检查、遗传性疾病和感染。亚组分析显示,男性、女性、老年和年轻患者的ADR信号存在差异。人类疱疹病毒 6 感染和剥脱性皮炎是 CBZ 引起的一致的 ADR,不受年龄或性别的影响。研究还发现了以前被忽视的 ADR,如骨代谢异常、眼毒性和耳毒性。许多与 CBZ 相关的 ADR 仍未得到充分报告。加强对癫痫患者使用 CBZ 的监测和信息传播至关重要。必要时,应考虑调整高危人群的用药方案,并可能结合针灸、传统中药或替代抗癫痫药物。
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
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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