899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure

医学 不利影响 食品药品监督管理局 监管机构 重症监护医学 医疗急救 内科学 公共行政 政治学
作者
Kurosh Parsi,Lois Zhang,Mark S Whiteley,Selene Vuong,Mina Kang,Nikita Naidu,Joseph Gracé,David Connor
出处
期刊:Phlebology [SAGE]
卷期号:39 (2): 80-95 被引量:20
标识
DOI:10.1177/02683555231211086
摘要

Objective The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies. Methods The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data. Results The TPLC contained 899 reports which included 13 cases of death, 7 strokes, 211 thromboembolic events, and 482 immune reactions. The DAEN recorded three reportable adverse events, and the MHRA recorded seven adverse incidents including one death. Conclusion CAC is associated with serious adverse events including death. These events are under-reported in the medical literature and only sub-optimally reported to the regulatory agencies.
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
刚刚
刚刚
xuwenwen完成签到,获得积分10
刚刚
苏卿应助机灵的秋凌采纳,获得10
刚刚
淡淡菀完成签到,获得积分10
1秒前
1秒前
星辰大海应助九鹤采纳,获得10
1秒前
CA完成签到,获得积分10
2秒前
HeHe完成签到,获得积分10
2秒前
3秒前
机灵夜云发布了新的文献求助10
3秒前
芝麻糊完成签到,获得积分10
4秒前
4秒前
万能图书馆应助沉静丹寒采纳,获得10
5秒前
5秒前
5秒前
6秒前
李健应助小野采纳,获得10
6秒前
lyl完成签到,获得积分10
6秒前
lihua发布了新的文献求助10
8秒前
山猪吃细糠完成签到 ,获得积分10
8秒前
vans如意完成签到 ,获得积分10
9秒前
9秒前
共享精神应助甜晞采纳,获得10
9秒前
10秒前
吃猫的鱼完成签到,获得积分10
10秒前
超级大饼完成签到,获得积分10
10秒前
10秒前
10秒前
11秒前
ala发布了新的文献求助10
11秒前
11秒前
顾矜应助nong12123采纳,获得10
12秒前
香蕉觅云应助yanzu采纳,获得10
12秒前
christal完成签到,获得积分10
13秒前
刘xiansheng发布了新的文献求助10
14秒前
14秒前
14秒前
14秒前
汉堡包应助白桦采纳,获得10
14秒前
高分求助中
Production Logging: Theoretical and Interpretive Elements 2700
Mechanistic Modeling of Gas-Liquid Two-Phase Flow in Pipes 2500
Kelsen’s Legacy: Legal Normativity, International Law and Democracy 1000
Handbook on Inequality and Social Capital 800
Conference Record, IAS Annual Meeting 1977 610
Interest Rate Modeling. Volume 3: Products and Risk Management 600
Interest Rate Modeling. Volume 2: Term Structure Models 600
热门求助领域 (近24小时)
化学 材料科学 生物 医学 工程类 有机化学 生物化学 物理 纳米技术 计算机科学 内科学 化学工程 复合材料 基因 遗传学 物理化学 催化作用 量子力学 光电子学 冶金
热门帖子
关注 科研通微信公众号,转发送积分 3546536
求助须知:如何正确求助?哪些是违规求助? 3123667
关于积分的说明 9356348
捐赠科研通 2822331
什么是DOI,文献DOI怎么找? 1551314
邀请新用户注册赠送积分活动 723326
科研通“疑难数据库(出版商)”最低求助积分说明 713699