A Case Report of Contamination and Toxicity of Ethylene Glycol and Diethylene Glycol on Drugs in Indonesia

Abstract

Every individual has a right to access safe medicine. However, in fact, drug contamination still occurs in several countries. The Indonesian authorities through the Indonesian Food and Drug Supervisory Agency or Badan Pengawas Obat dan Makanan (BPOM) Indonesia declared five drug products contaminated with ethylene glycol (EG) and diethylene glycol (DEG) on October 19, 2022. The concentration of the chemicals exceeded 0.5 mg/kg body weight per day based on recognized pharmacopeia and BPOM Indonesia. Based on the pharmaceutical issues, this study aimed to disseminate information on drugs contaminated with EG and DEG in Indonesia along with their effects. The descriptive method with a case report approach was used in this study. Secondary data of previous research were obtained from the website of the Indonesian state authorities such as the Indonesian Ministry of Health, the Food and Drug Supervisory Agency, and some journal databases. Data collection was carried out from October 12 to December 22, 2022. A total of 323 cases of acute kidney injury and 190 deaths in children were reported by the Indonesian Ministry of Health. The investigation results show that contamination from EG and DEG as solvents was found in some drugs; as a result, the drugs did not meet the quality standards. A total of 103 syrup drugs contaminated had caused acute kidney injury and six companies that produced contaminated drugs were given several sanctions for their negligence.