WHO issues alert against four India-made paediatric cough syrups after 66 children die in Gambia

Geneva, October 5, 2022

The World Health Organization (WHO) today issued a medical product alert against four India-made paediatric cough syrups after the death of 66 children in the West African country of Gambia.

WHO Director-General Tedros Adhanom Ghebreyesus said at a media briefing that the alert for issued for the "four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children".

"The loss of these young lives is beyond heartbreaking for their families.

"The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India," he said.

"WHO is conducting further investigation with the company and regulatory authorities in India.

"While the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients," he added.

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

"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.

"Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions," the WHO alert said.

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.

"All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death," it said.

"It is important to detect and remove these substandard products from circulation to prevent harm to patients," the WHO said in its advice to regulatory authorities and the public.

"WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised," it added.

NNN