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Substandard paediatric medicines linked to 66 child deaths

The World Health Organization (WHO) has made a Medical Product Alert that refers to four substandard (contaminated) products, identified in The Gambia and reported to WHO in September 2022.

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India).

An increase in cases of acute kidney injury among children under five

The alert follows the warning issued by Gambia’s medical authorities in July over an increase in cases of acute kidney injury among children under five, reports Pharma Logistics IQ. A number of these children fell ill three to five days after taking a paracetamol syrup sold locally.

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WHO Director-General Tedros Adhanom Ghebreyesus said last Wednesday that the UN health agency was investigating the deaths of the 66 children from acute kidney injuries with India’s regulators and the drug maker.

To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products. India’s Health Ministry has begun testing samples, it said in a statement, and added that Maiden Pharmaceuticals is not licensed to distribute the four products in India.

 

Photo of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup: WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products

 

Unacceptable amounts of diethylene glycol and ethylene glycol as contaminants

Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. 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.

All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities, states the WHO.

“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death. It is important to detect and remove these substandard products from circulation to prevent harm to patients,” the WHO states.

A global health problem

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

An estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified, according to the WHO. Substandard and falsified medical products also contribute to antimicrobial resistance and drug-resistant infections.

Anti-malarials and antibiotics are amongst the most commonly reported substandard and falsified medical products.

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