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NAFDAC raises alarm on harmful pediatric cough syrups

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 the Gambia following the use of four substandard cough syrups.

A statement from the agency on Sunday, signed by the Director General, Prof Moji Adeyeye, said the four products are Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup and Magrip N cold syrup.

It said laboratory analyses of samples of the four products confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

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Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

The statement read in part, “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 the World Health Organisation on the safety and quality of these products.”

NAFDAC described the cough syrups as unsafe for use, especially in children, as it may result in serious injury or death.

The statement added that the products are not registered by NAFDAC and therefore should not be in circulation.

“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 said.

It continued, “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.”

NAFDAC also enjoined healthcare professionals and consumers to report any suspicion of adverse drug reactions and substandard and falsified medicines to the agency.

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