The World Health Organization (WHO) Medical Product Alert has identified four substandard cough products that are deadly for use in children.
The medications detected in the Gambia last month are suspected to have been distributed through informal access to other African markets.
They are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The manufacturer of these products is Maiden Pharmaceuticals Limited in Haryana, India, and the company has not provided guarantees to WHO on the safety and quality of these products.
Substandard medical products are products that fail to meet either their quality standards or specifications and are therefore out of specification.
According to WHO, laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
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.
WHO advised that all batches of these products should be considered unsafe until they can be analysed by the relevant national regulatory authorities.
It warned that the products are unsafe and their use, especially in children, may result in serious injury or death.
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“It is important to detect and remove these substandard products from circulation to prevent harm to patients,” the global health body warned in an official alert on Wednesday.
WHO requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by the products. Increased surveillance of the unregulated market is also advised.
All medical products are advised to be approved and obtained from authorised suppliers. The products’ authenticity and physical condition should be carefully checked. And advice should be sought through a healthcare professional when in doubt.
National regulatory and health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.
“If you have these substandard products, please do not use them. If you, or someone you know, have used these products or suffered any adverse reaction after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Pharmacovigilance Centre,” it said.
