The World Health Organization (WHO) has raised an alarm after it linked the death of about 66 Children to the consumption of Cough syrup in Gambia.
WHO raised the alarm in a statement via its website @www.who.int titled Substandard (contaminated) paediatric medicines identified in WHO region of Africa.
According to WHO, the syrups are likely responsible for acute kidney injuries and the deaths of at least 66 children.
Also the Apex health organization disclosed that Maiden Pharmaceuticals an bases Indian company which manufactures the products has failed to provide guarantees about their safety.
Some of the cough syrups identified by WHO includes, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Part of the statement reads: “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 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.”
“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, WHO explained.
“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.”
Similarly, WHO adviced regulatory authorities and the public too detect and remove these substandard products from circulation to prevent harm to patients.”
“WHO requests 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.”
“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/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.”
“National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country. If you have any information concerning the manufacture or supply of these products, please contact WHO via rapidalert@who.int.”
The intervention of WHO follows a discovery by the Gambiam medical authorities – which is a popular tourist destination – that there was an increase in cases of acute kidney injury among children under the age of five in late July.
Meanwhile, the Gambian government has suspended the use of all paracetamol syrups and instead urged citizens to use tablets instead.