UNAIR NEWS – The issue of syrup medicines linked to acute kidney injuries in children drew serious attention. The Indonesian Food and Drug Authority (BPOM) and Health Ministry review the issue by checking various syrup medicines. The result revealed that the medicine contained compound contamination of ethylene glycol (EG) and diethylene glycol (DEG). Is it true that these compounds cause acute kidney failure in children?
To UNAIR NEWS (2/11/2022), Prof Junaedi Khotib SSi Apt MKes Ph.D., the Dean of Universitas Airlangga Faculty of Pharmacy (FF), stated that ethylene glycol and diethylene glycol are simple-structured compounds with high levels of toxicity. It is regulated by the European Food Safety Agency (EFSA), Food and Drug Administration (FDA), and is registered in the list of toxic substances.
“The compounds are prohibited within food and medicine. However, these compounds are contained as the impurities or contamination of the additional substances in the syrup medicine production,” he said.
Ethylene Glycol (EG) and Diethylene Glycol (DEG) limits
Prof Junaedi said that the impurities limit of EG and DEG in food and medicine had been set. In Indonesia, the impurities EG and DEG cannot exceed 0.1 mg. BPOM has also determined the level of impurities in the products that should not be distributed in the market.
“It has been set that the contamination cannot exceed 0.1 mg. For example, if the pharmaceutical industry uses propylene glycol as an additive for syrup, the impurities will automatically follow. In EG and DEG cases, if the levels exceed, the products are banned,” Junaidi said.
In some cases, the EG and DEG contaminants may exceed the safe limit due to changes in the source of raw materials to the stability of the material. Therefore, the pharmaceutical industry should be responsible for implementing customer awareness and Pharmacovigilance to ensure product safety.
“In some cases, the EG increased to the safe limit. It can be drastic, from 0.1 mg to 48 mg or 480 percent higher. On this matter, the pharmaceutical industry has responsibilities in customer awareness and pharmacovigilance to make sure their products are safe,” he added.
EG and DEG reactions
Prof. Junaidi further explained the metabolism and reactions within the human body when exposed to EG and DEG, which leads to acute kidney failure and death.
“The EG and DEG in the body will be excreted. The problem started during the filtration process in the kidney, which turns into glycolic acid. It leads to decreasing blood Ph. As a result, the oxygen drops. The early symptom of kidney failure is shortness of breath due to the lack of oxygen,” he said.
The EG and DEG exposures in the kidney also lead to another problem. If the compounds get in the proximal tubules, it leads to cell death. The glycolic acid will turn into oxalic acid in the kidney cells and react with calcium to form calcium oxalate (kidney stones).
“It’s clear that EG and DEG will cause kidney failure. Why? Firstly, it causes decreasing oxygen in the blood. Secondly, it kills kidney cells and creates calcium oxalate in the kidneys. As a result, the filtration in the kidney will be disrupted. In the end, the urine will be decreased or even fully blocked,” he added.
Author: Yulia Rohmawati
Editor: Khefti Al Mawalia
