The National Agency for Food and Drugs Administration and Control (NAFDAC) has notified Healthcare providers and the public of the death of 66 children in Gambia following the use of four substandard cough syrups as reported by WHO in September 2022.
This was contained in a statement issued by the Agency on Sunday, October 9, 2022.
The four products as disclosed by the statement were Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
It said, laboratory analysis of samples of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
The Health agency explained that, “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.
“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”.
NAFDAC further stated that the substandard products earlier announced were unsafe and their use, especially in children, may result in serious injury or death.
It also noted that the products were not registered by NAFDAC and therefore should not be in circulation.
In addition, the agency implored everyone in the supply chain of the four listed drugs to desist from it:
“To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.
“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 authorized/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.
“Healthcare professionals and consumers are encouraged to report any suspicion of adverse drug reaction and substandard and falsified medicines to NAFDAC”, it said.