Medical Product Alert: WHO identifies contaminated paediatric medicines in Africa

October 7, 2022

The World Health Organisation (WHO), Africa region has issued a medical product alert after identifying substandard (contaminated) paediatric medicines in The Gambia.

In a statement by WHO the Medical Product Alert refers to four substandard products, identified 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 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). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.

According to WHO, the 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.

Risks
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.

The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.

WHO however Advised regulatory authorities and the public that it is important to detect and remove these substandard products from circulation to prevent harm to patients, while requesting increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised.

“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”.