Critical evaluation of endotoxin contamination in intravenous solutions: A call for enhanced regulatory oversight and quality control

Q3 Medicine
K.T. Muhammed Favas , Guru Datt Sharma , Sanjit Sah
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引用次数: 0

Abstract

The recent identification of bacterial endotoxins in Ringer’s Lactate (RL) from a manufacturing batch by M/s. Vision Parenteral Pvt. Ltd. has raised significant concerns regarding the safety of intravenous solutions. These endotoxins, originating from Gram-negative bacteria, can trigger severe systemic inflammatory responses, worsening conditions like haemorrhagic shock and leading to organ dysfunction and increased mortality. The interaction between RL and endotoxins is particularly problematic, as it can exacerbate inflammation, disrupt fluid balance, and complicate metabolic and immune responses. This situation underscores significant gaps in pharmaceutical manufacturing practices and highlights the urgent need for stricter regulatory oversight and quality control. The healthcare community must reassess the use of RL in clinical settings, particularly in cases where endotoxin contamination could pose a significant risk, to protect patient health and safety.

严格评估静脉注射液中的内毒素污染:呼吁加强监管和质量控制
最近,M/s. Vision Parenteral Pvt Ltd 生产的一批乳酸林格氏液(RL)中发现了细菌内毒素,这引起了人们对静脉注射液安全性的极大关注。Ltd.生产的一批乳酸林格氏液(RL)中发现了细菌内毒素,这引起了人们对静脉注射溶液安全性的极大关注。这些内毒素来自革兰氏阴性细菌,可引发严重的全身炎症反应,使失血性休克等情况恶化,导致器官功能障碍和死亡率上升。RL 与内毒素之间的相互作用尤其成问题,因为它会加剧炎症、破坏体液平衡并使新陈代谢和免疫反应复杂化。这种情况凸显了药品生产实践中存在的巨大差距,并强调了对更严格的监管和质量控制的迫切需要。医疗界必须重新评估 RL 在临床环境中的使用,尤其是在内毒素污染可能造成重大风险的情况下,以保护患者的健康和安全。
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
Clinical Infection in Practice
Clinical Infection in Practice Medicine-Infectious Diseases
CiteScore
2.10
自引率
0.00%
发文量
95
审稿时长
82 days
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