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伪造的咳糖导致儿童急性功能衰竭死亡:教训仍然没有被吸取
Devaraj Ezhilarasan1, Munusamy Karthick1
1Department of Pharmacology, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, 600 077, India.
Regulatory toxicology and pharmacology : RTP
|December 21, 2025
概括
2025年的印度悲剧揭示了24名儿童死于COLDRIF咳糖,污染了有毒的乙烯甘醇 (DEG). 这突显了儿科药品的关键风险,原因是监管失败和质量控制不良.
科学领域:
- 毒理学 毒理学 毒理学
- 儿科医学 儿科医学
- 制药品质量控制 制药品质量控制
背景情况:
- 儿童咳糖中的乙烯甘醇 (DEG) 污染导致2025年24名印度儿童的致命急性功能衰竭.
- 涉案的咳糖COLDRIF (批量SR-13) 含有46.28%的DEG,这是一种毒性溶剂,替代了制药级辅助剂.
研究的目的:
- 调查印度24名儿童因食用受污染的儿科咳糖而死亡的原因.
- 为了确定毒剂及其作用机制导致急性功能衰竭.
- 突出导致这种制药污染的系统性问题.
主要方法:
- 对儿童咳糖批次的污染物的分析.
- 对受影响儿童的临床数据和活检结果的审查.
- 对二乙烯糖醇及其代谢物进行毒理学评估.
主要成果:
- 脏活检证实了受影响儿童的急性管状缩.
- 乙烯基醇 (DEG) 被确定为污染物,通过其代谢产物对毒性和代谢性酸化负责.
- 污染突出了严重的监管缺陷和制药制造业不充分的质量控制.
结论:
- 在儿科药物中乙烯甘醇 (DEG) 造构成了全球反复出现的风险.
- 严格遵守良好制造实践 (GMP) 和强有力的监管监督对于防止未来事件至关重要.
- 需要采取紧急措施,以确保制药品中使用的辅助剂的安全性和质量.
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