The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup manufactured by Maiden Pharmaceuticals Limited

The World Health Organisation on Wednesday issued a medical product alert over four cough and cold syrups made by Maiden Pharmaceuticals in India, warning they could be linked to acute kidney injuries and deaths of 66 children in The Gambia.

“This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore “out of specification,” the WHO statement read.

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup manufactured by Maiden Pharmaceuticals Limited from Haryana in India. The manufacturer has not provided guarantees to WHO on the safety and quality of these products.

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

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Risks of cough syrup

According to the WHO, 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, WHO statement added.

It said all batches of these products should be considered unsafe until they can be analyzed by the relevant national regulatory authorities.

WHO advice

The WHO has called on regulatory authorities and the public to detect and remove these substandard products from circulation to prevent harm to patients.

The world health body requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. It also advised increased surveillance of the informal and unregulated markets.

“All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt,” the WHO advised.

“If you have these substandard products (cough syrups from Maiden Pharmaceuticals), please do not use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre,” the WHO added.