A worldwide health alert has been issued over four potentially deadly cold and cough syrups after 66 children died.
The World Health Organization's intervention came after medical authorities in Gambia began detecting an increase in cases of acute kidney injury among children under the age of five in late July.
Gambia - a popular tourist destination - has since suspended the use of all paracetamol syrups.
The country is now urging people to use tablets instead.
The four products "may have been distributed, through informal markets, to other countries or regions", the WHO said.
WHO chief Tedros Adhanom Ghebreyesus said the four cold and cough syrups “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 WHO identified the medicines as:
- Promethazine Oral Solution
- Kofexmalin Baby Cough Syrup
Makoff Baby Cough Syrup
Magrip N Cold Syrup
The products were manufactured by an Indian company, Maiden Pharmaceuticals, which had failed to provide guarantees about their safety, the WHO added.
Mr Ghebreyesus said the WHO is “conducting further investigation with the company and regulatory authorities in India”.
Indian officials say they have asked the WHO to share evidence of the link between the syrups and the deaths.
The WHO said laboratory analysis of samples of products "confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants".
The health alert reads: "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 analysed 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 added: "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 and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre."
