Adulterated cough syrup caused acute kidney failure deaths in children: lessons have still not been learnt

IF 4.3 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology Pub Date : 2026-03-01 Epub Date: 2025-12-19 DOI:10.1016/j.yrtph.2025.106015

Devaraj Ezhilarasan, Munusamy Karthick

引用次数: 0

Abstract

In 2025, 24 children in India died after consuming COLDRIF, a paediatric cough syrup, due to acute kidney failure. Batch SR-13 from Sresan Pharmaceuticals in Tamil Nadu, India,was contaminated with 46.28 % diethylene glycol (DEG), a toxic solvent used in place of pharmaceutical-grade excipients. Kidney biopsies from children confirmed acute tubular necrosis. DEG toxicity, via its metabolites 2-hydroxyethoxyacetic acid and diglycolic acid, causes metabolic acidosis and nephrotoxicity. Global incidents highlight repeated risks of DEG adulteration in children medicines. Regulatory lapses and poor-quality control remain major contributors. Strict adherence to Good Manufacturing Practices and vigilant regulatory oversight are essential to prevent such fatal outbreaks.

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掺假止咳糖浆导致儿童急性肾衰竭死亡：至今仍未吸取教训。

2025年，印度有24名儿童在食用COLDRIF（一种儿科止咳糖浆）后死于急性肾衰竭。批次SR-13被46.28%的二甘醇（DEG）污染，这是一种用于代替药用级赋形剂的有毒溶剂。组织病理学证实为急性肾小管坏死。DEG毒性通过其代谢物2-羟基乙氧基乙酸和二乙醇酸引起代谢性酸中毒和肾毒性。全球事件凸显了儿童药品中DEG掺假的反复风险。监管失误和质量控制不力仍然是主要原因。严格遵守良好生产规范和警惕的监管监督对于防止此类致命疫情至关重要。

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

Regulatory Toxicology and Pharmacology 医学-毒理学

CiteScore

6.70

自引率

8.80%

发文量

147

审稿时长

58 days

期刊介绍： Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)