Beware: India-made Cough Syrups Linked To The Gambia 69 Child Deaths May Be In Nigeria, NAFDAC Alerts

The National Agency for Food and Drugs Administration and Control (NAFDAC) has raised the alarm over four deadly cough syrups currently in circulation in The Gambia and linked to the death of 69 child deaths may be its way into the Nigerian market.

Tasking healthcare providers in the country to be on the watch-out, NAFDAC listed the four paediatric cough syrups as: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. 

Already, India’s Health Ministry said the World Health Organisation (WHO) had informed the country’s drug regulator the medicines may have been contaminated with diethylene glycol or ethylene glycol

Gambia’s Health Minister Ahmadou Lamin Samateh told journalists in Banjul Saturday that the child deaths from kidney injury linked to the contaminated India-made cough syrups have risen to 69.

Samateh, who said he lost his nephew to acute kidney injury on Wednesday, told the media that three more children died as of Saturday, bringing the toll to 69. A day earlier Gambian President Adama Barrow said cases and deaths were “under control, with only two diagnoses in the last two weeks.”

Barrow had ordered the suspension of the license of the suspected pharmacy and importer of the cough syrups and ordered his foreign minister to take up the matter with the Indian ambassador to Banjul, according to a presidential statement late Saturday. 

In India, Maiden Pharmaceuticals Ltd. was cited by Mint as saying government agencies visited the drugmaker’s factory on four occasions from Oct. 1 to 7, and samples were taken by the Central Drugs Standard Control Organization for testing.

The company was cited as saying it had valid approvals for the export of the products in question, which weren’t sold in India, and had obtained raw materials from “certified and reputed companies.”

In Gambia, the suspected pharmacy owner and importer of the cough syrups and some senior officials of the Medicines Control Agency have been called in for questioning by the police, who said they have opened an investigation into the deaths.

Meanwhile, NAFDAC said in a statement, on Sunday that the children who have died following the use of the four substandard cough syrups as reported by the World Health Organisation (WHO).

The regulatory agency explained that laboratory analysis of samples of the four syrups confirmed 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. Unfortunately, the manufacturer of these products, Maiden Pharmaceuticals Limited, Haryana, India, has not provided guarantees to WHO on the safety and quality of these products.”

NAFDAC warned Nigerians to consider all batches of these products  unsafe and that it has not registered them. 

“The substandard products in this alert are unsafe and their use, especially in children, may result in serious injury or death. 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.”

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