Contamination Risks in Children’s Cough Syrup: Experts Warn
What prompted WHO to issue these alerts?
In the past five months, the WHO has issued three alerts advising against the use of particular over-the-counter medications for children.
The warnings were issued following the deaths of at least 300 children in countries such as The Gambia, Indonesia, and Uzbekistan.
Medical product alerts were issued for Africa in October 2022, south-east Asia in November 2022, and Europe in January 2023.
The WHO only issues these warnings when an independent laboratory analysis confirms that a product is substandard or counterfeit and poses a significant risk to public health.
The threat must also transcend national borders.
Contamination Risks in Children’s Cough Syrup: Experts Warn. Children died after ingesting cough syrup containing ethylene glycol and diethylene glycol, prompting WHO medical product alerts.
Some of the children were only five years old.
Cases have been reported in at least seven nations.
What are ethylene glycol and diethylene glycol?
Both ethylene glycol and diethylene glycol are sweet-tasting, toxic alcohols.
They are utilized extensively in windshield wiper fluids and engine coolants.
Many food ingredients and medical solvents (such as propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol) may also contain trace amounts of these compounds as contaminants.
This occurs when there are inadequate manufacturing and testing standards.
Medical solvents are commonly used to dissolve a medicine’s constituents.
Over the years, ethylene glycol and diethylene glycol contamination poisonings have been primarily associated with paracetamol-containing solutions.
In cough syrups, paracetamol is beneficial and safe for children with infections.
It is a painkiller that effectively reduces fever without causing stomach irritation, unlike aspirin or ibuprofen.
Are they harmful?
Both ethylene and diethylene glycol are considered to be toxic. The lethal oral dose ranges between 1,000 and 1,500 milligrams per kilogram.
A lethal dose of pure ethylene glycol for a child weighing 20 kilograms would be approximately 28 milliliters or six teaspoons.
However, it is also possible to cause toxicity through the consumption of much lower doses over several days and weeks. The WHO’s safe level for these chemicals is therefore only 0.5 milligrams per kilogram per day.
This is equivalent to one-fifteenth of a teaspoon per day.
The fact that relatively large quantities of these glycols must be consumed before symptoms of contamination manifest is what makes them so potentially hazardous.
The additional risk posed by cough syrups is that symptoms of ethylene glycol and diethylene glycol contamination, such as drowsiness, can sometimes be observed in children who have not taken contaminated medicine, and can be misinterpreted as normal in a child with a cough or fever. It is possible for guardians and medical professionals to not detect a problem until it is too late.
What function does paracetamol serve?
To comprehend the possible role of paracetamol in these poisonings, it is necessary to comprehend what happens to ethylene glycol and diethylene glycol within the body.
To become toxic, these glycols must be transformed into glycolaldehyde and then glyoxylic acid.
Glyoxylic acid can accumulate in the kidneys and cause damage, leading to death from renal failure.
A certain concentration of the coenzyme nicotinamide adenine dinucleotide (NAD+) triggers the conversion. Mitochondria, which are small structures in human cells that regulate numerous chemical reactions in the body, regulate NAD+.
In a recent study, we demonstrated that paracetamol inhibits mitochondria at the normal dose required to treat fever.
Thus, it influences the level of NAD+ and, consequently, the transformation of glycols into toxins.
Children who consume paracetamol preparations contaminated with glycols may be at risk.
We believe that the combination of paracetamol and glycols in medicines, even when the contamination is relatively low but above the WHO-acceptable limit of 0.5 mg/kg of body weight per day, could be fatal.
Due to the increased metabolism of ethylene glycol and diethylene glycol, preparations containing standard levels of paracetamol are more likely to have adverse effects on children than other medications or foods that do not disrupt mitochondrial function.
Other medicines and foods contaminated with trace amounts of ethylene glycol and diethylene glycol are likely undetected because they do not contain paracetamol.
What measures must be taken to avert future deaths?
ethylene glycol and diethylene glycol poisoning can be treated if detected early enough.
The two most common overdose antidotes are fomepizole and ethanol.
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Both decrease the amount of harmful ethylene glycol and diethylene glycol metabolites produced by the body.
Mass poisonings demonstrate the need for more vigilant monitoring of paracetamol-containing medications.
Paracetamol-containing medications are typically very safe for children.
To prevent future deaths associated with cough syrup, parents and medical professionals should consider glycol poisoning as a possibility if children exhibit signs of intoxication and drowsiness after taking the medication.
Typically, these incidents occur in countries classified as the global south.
Manufacturers and regulatory authorities in these nations are also responsible for the protection of children.
