Ethylene and diethylene glycol contamination in medicines: a global pharmaceutical safety issue

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Abstract

Introduction. Ethylene glycol (EG) and diethylene glycol (DEG) are toxic compounds widely used in industry. They can contaminate pharmaceutical products due to the use of substandard excipients or deliberate adulteration. Their presence, even in small amounts, poses a serious risk to human health and life. The ingestion of such drugs, especially by children, can cause severe poisoning with damage to the kidneys, liver, and nervous system, and may even lead to fatal outcomes.

Objective. The study aims to analyze historical cases of mass EG and DEG poisonings, investigate the causes of their presence in pharmaceuticals, and examine their toxicological properties, metabolic pathways, and clinical manifestations of intoxication.

Materials and methods. The research utilized data from scientific publications, reports on mass poisoning incidents, investigations and regulatory documents.

Results. The review provides characteristics of EG and DEG, their industrial applications, metabolic pathways, mechanisms of toxicity, and key symptoms of poisoning. It also explores the reasons for their presence in pharmaceutical products and historical cases of mass poisonings. Special emphasis is placed on the urgent need for enhanced quality control measures and implementation of high-sensitivity analytical methods to prevent future incidents.

Conclusion. To minimize risks of repeated intoxications from EG or DEG -contaminated medications, it is essential to strengthen regulatory requirements and quality control systems, employ advanced analytical techniques, and improve international regulatory cooperation. A comprehensive approach incorporating these measures will enhance drug safety and prevent future poisoning cases.

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About the authors

Nikita Grigorievich Paskar

Sechenov First Moscow State Medical University

Email: nnikpaskar@yandex.ru
ORCID iD: 0009-0002-6656-6667
SPIN-code: 8269-0440

5th-Year Student at the Nelyubin Institute of Pharmacy

Russian Federation, Moscow

Natalia Valeryevna Pyatigorskaya

Sechenov First Moscow State Medical University

Email: pyatigorskaya_n_v@staff.sechenov.ru
ORCID iD: 0000-0003-4901-4625
SPIN-code: 8128-1725

Doctor of Pharmaceutical Sciences, Professor, Corresponding Member of the RAS, Head of the Department of Industrial Pharmacy

Russian Federation, Moscow

Elena Olegovna Bakhrushina

Sechenov First Moscow State Medical University

Email: bakhrushina_e_o@staff.sechenov.ru
ORCID iD: 0000-0001-8695-0346
SPIN-code: 9537-1297

Doctor of Pharmaceutical Sciences, Associate Professor at the Department of Pharmaceutical Technology of the Nelyubin Institute of Pharmacy

Russian Federation, Moscow

Sergey Petrovich Senchenko

Research and testing center “FARMOBORONA” LLC

Email: senchenko_sergey@farmoborona.ru
ORCID iD: 0000-0003-0212-3840
SPIN-code: 4860-0144

Doctor of Pharmaceutical Sciences, Associate Professor, Head of the Department for Development of Analytical Methods

Russian Federation, Korolev, Moscow Region

Sevara Dzhurabekovna Marchenko

Sechenov First Moscow State Medical University

Author for correspondence.
Email: marchenko_s_d@staff.sechenov.ru
ORCID iD: 0000-0002-0177-6826
SPIN-code: 7605-2080

Candidate of Pharmaceutical Sciences, Associate Professor at the Department of Organization and Management in the Field of Medicines Circulation of the Institute of Professional Education

Russian Federation, Moscow

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