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

Year: 2024

Type: article

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.

Source: Clinical Infection in Practice

DOI: 10.1016/j.clinpr.2024.100385

Authors: K.T. Muhammed Favas, Guru Datt Sharma, Sanjit Sah

Institutions: Saveetha University, Graphic Era University, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D.Y. Patil Vidyapeeth, Pune, Dr D Y Patil Dental College & Hospital

Language: English

Topic: Sepsis Diagnosis and Treatment

Subfield: Epidemiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,000