• Tuesday, April 23, 2024
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WHO raises fresh alarm over substandard paediatric syrups from Indonesia

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The World Health Organization (WHO) has raised a fresh alarm over eight substandard paediatric syrups identified in Indonesia.

The warning is coming nearly a month after it detected four dangerous cough syrups with fatal implications from India.

The eight products newly detected are Termorex syrup, Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, Paracetamol Drops, Paracetamol Syrup (mint) and Vipcol Syrup.

Laboratory analysis of samples by the authorities in Indonesia shows that the products contain unacceptable amounts of ethylene glycol and diethylene glycol as contaminants, WHO said in a statement released Wednesday.

“Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore, out of specification,” the statement read.

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“To date, these products have been identified in Indonesia. They may however have marketing authorizations in other countries. These products may have been distributed, through informal markets, to other countries or regions.”

Ethylene glycol and diethylene glycol are toxic content for human consumption and can prove fatal.

This makes the products unsafe for use, especially in children, and may result in serious injury or death, WHO stated.

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

The global health body urges regulatory authorities to detect and remove these substandard products from circulation to prevent harm to patients.

It has called for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products.

“National regulatory and health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country,” it said.

It noted that manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, or glycerin are urged to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.

It also recommends that all medical products must be approved and obtained from authorized or licensed suppliers.

The products’ authenticity and physical condition should be carefully checked.

The National Agency for Food and Drug Administration and Control is yet to react to the warning and it’s not clear yet if the the products are circulating in Nigeria.