The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to substandard cough syrups circulating in The Gambia, calling for vigilance.
The alert, with No. 040/2022, signed by NAFDAC Director-General, Prof. Mojisola Adeyeye, was made available on Sunday in Abuja.
The statement identified the cough syrups as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, saying that they might have been contaminated.
The director-general, in the statement, also notified healthcare providers and the public of the death of 66 children in The Gambia, following the use of the substandard cough syrups, as reported by WHO in September 2022.
According to her, laboratory analysis of samples of the four products confirms that they contain 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.
“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.
“All the batches of these products listed above should be considered unsafe,” Adeyeye said.
The director-general added that the
substandard products were unsafe and that their use, especially in children, might result in serious injury or death.
She said that the four products were already identified in The Gambia and might have been distributed, through informal markets, to other countries or regions.
According to her, the products are not registered by NAFDAC and should, therefore, not be in circulation.
Adeyeye implored 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.
She said that all medical products must be obtained from authorised/licensed suppliers, adding that their authenticity and physical condition must be carefully checked.
The director-general also advised members of the public in possession of the listed products to discontinue their sale or use and submit their 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 them or suffered any adverse reaction/event, you are advised to seek immediate medical advice from a qualified healthcare professional,” she said.
Adeyeye also encouraged healthcare professionals and consumers to report any suspicion of adverse drug reaction and substandard and falsified medicines to NAFDAC on 0800-162-3322.
“The public is also advised to report any incident through this email: [email protected].
