Safety profile of clobazam in the real world: an analysis of FAERS database and systematic review of case reports

克洛巴扎姆 医学 嗜睡 不利影响 麻醉 数据库 药理学 癫痫 精神科 计算机科学
作者
Pengjiao An,Xin Liu,Bo Zhang
出处
期刊:Expert Opinion on Drug Safety [Taylor & Francis]
卷期号:23 (1): 119-128 被引量:4
标识
DOI:10.1080/14740338.2023.2204227
摘要

Background Most of the safety data of clobazam came from well-designed clinical trials, while the real-world information is insufficient.Research design and methods We performed a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database through OpenVigil 2 and conducted a systematic review of case reports regarding adverse drug reactions (ADR) linked to clobazam.Results The analysis of FAERS identified 595 ADR signals. Nervous system disorders cantains the most positive signals among all system organ classes (SOCs). Except for seizure (n = 1696) and somnolence (n = 813), drug interactions (n = 492) were the most frequently reported positive signals. A total of 502 unique citations were initially retrieved and 31 individual cases from 28 publications were included. Skin reactions were the most reactions (n = 9), containing three types of severe reactions not alerted in the instruction. Five cases were caused by interactions between clobazam and other antiepileptic drugs, etravirine-based antiretroviral therapy, omeprazole, or meropenem. One patient died of aspiration pneumonia.Conclusions Clinicians must pay attention to severe skin reactions and monitor the signs of suspicious respiratory infections/inflammations and central sedation. Patients with skin reactions will benefit from the withdrawal of clobazam and the treatment with glucocorticoids. The drug reactions between clobazam with severe or moderate cytochrome P450 (CYP) 3A4 or CYP2C19 inhibitors or other antiepileptic drugs should also be alerted.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
我爱蓝胖子完成签到,获得积分10
刚刚
Along完成签到,获得积分10
刚刚
静修者z发布了新的文献求助10
刚刚
小尘埃完成签到,获得积分10
刚刚
kma完成签到,获得积分10
1秒前
2秒前
典雅的小天鹅完成签到,获得积分10
3秒前
隐形曼青应助淘宝叮咚采纳,获得10
4秒前
共享精神应助淘宝叮咚采纳,获得10
4秒前
liu123479完成签到,获得积分10
4秒前
KX2024发布了新的文献求助10
4秒前
4秒前
tomf完成签到,获得积分10
4秒前
研友_ZegMrL完成签到,获得积分10
5秒前
zz完成签到,获得积分10
5秒前
云淡风轻完成签到,获得积分10
5秒前
金刚芭比狲大娘完成签到,获得积分10
5秒前
6秒前
量子星尘发布了新的文献求助20
7秒前
yangzhang完成签到,获得积分10
8秒前
catch完成签到,获得积分10
8秒前
WLL完成签到,获得积分10
8秒前
清新的剑心完成签到 ,获得积分10
8秒前
英俊的铭应助沉默的阁采纳,获得10
8秒前
科研通AI2S应助Shandongdaxiu采纳,获得10
11秒前
11秒前
蔷薇完成签到,获得积分10
12秒前
早早入眠完成签到,获得积分10
12秒前
TAboo完成签到,获得积分10
12秒前
平常雨泽完成签到 ,获得积分10
13秒前
花草般的清香完成签到,获得积分10
13秒前
创新完成签到,获得积分10
13秒前
14秒前
lbw完成签到 ,获得积分10
14秒前
望望旺仔牛奶完成签到,获得积分10
15秒前
shelemi发布了新的文献求助10
15秒前
sherry完成签到,获得积分10
16秒前
17秒前
量子星尘发布了新的文献求助10
17秒前
nyfz2002发布了新的文献求助10
17秒前
高分求助中
Production Logging: Theoretical and Interpretive Elements 2700
Neuromuscular and Electrodiagnostic Medicine Board Review 1000
Statistical Methods for the Social Sciences, Global Edition, 6th edition 600
こんなに痛いのにどうして「なんでもない」と医者にいわれてしまうのでしょうか 510
ALUMINUM STANDARDS AND DATA 500
Walter Gilbert: Selected Works 500
岡本唐貴自伝的回想画集 500
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 物理 生物化学 纳米技术 计算机科学 化学工程 内科学 复合材料 物理化学 电极 遗传学 量子力学 基因 冶金 催化作用
热门帖子
关注 科研通微信公众号,转发送积分 3666586
求助须知:如何正确求助?哪些是违规求助? 3225604
关于积分的说明 9763904
捐赠科研通 2935434
什么是DOI,文献DOI怎么找? 1607692
邀请新用户注册赠送积分活动 759302
科研通“疑难数据库(出版商)”最低求助积分说明 735250