National Agency for Food and Drugs Administration and Control (NAFDAC) has notified healthcare providers and the public of the death of 66 children in The Gambia, following the use of four substandard cough syrups.
NAFDAC, in a statement, yesterday, signed by its Resident Media Consultant, Sayo Akintola, said the four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
According to the agency, laboratory analysis of samples of the products confirmed they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
NAFDAC said the 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.
The manufacturer of the products is Maiden Pharmaceuticals Limited (Haryana, India).
Till date, the manufacturer has not provided guarantees to WHO on the safety and quality of the products.
NAFDAC said all batches of the products listed above should be considered unsafe.
“The substandard products in this alert are unsafe, and their use, especially in children, may result in serious injury or death,” it warned.
NAFDAC said the products are not registered by the agency, therefore should not be in circulation.
“These four products have been identified in The Gambia but may have been distributed, through informal markets to other countries or regions, NAFDAC said.
It added: “NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain, to avoid the importation, distribution, sale and use of the substandard cough syrups. All medical products must be obtained from authorised/licensed suppliers.
“The products’ authenticity and physical condition should be carefully checked. Members of the public in possession of the above-listed products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
“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.”