The deaths of dozens of young children in Gambia due to acute kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, the World Health Organization said on Wednesday.
The results, announced by WHO Director-General Tedros Adhanom Ghebreyesus, followed tests on several medicinal syrups that were suspected of causing 66 child deaths in the tiny West African country.
Tedros told reporters that the U.N. agency was conducting an investigation with Indian regulators and the company that made the syrups, New Delhi-based Maiden Pharmaceuticals Ltd.
Maiden Pharma didn't respond to calls from the Drugs Controller General of India, while the messages to the Drugs Controller General of India went unanswered. The WHO issued a medical product alert on Wednesday, asking regulators to remove Maiden Pharma products from the market.
The products may have been distributed elsewhere through informal markets, but have been identified only in Gambia, the WHO said in its alert.
The alert covers four products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The WHO said that there were unacceptable amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
In July, medical officers in Gambia raised the alarm after dozens of children began to fall ill with kidney problems. The deaths surprised medics before a pattern emerged: dozens of patients younger than five were affected three to five days after taking a locally sold paracetamol syrup.
Gambia's health services director, Mustapha Bittaye, said similar problems have been detected in other syrups but that the ministry is awaiting confirmation of the results.
He said the number of deaths has tapered off in recent weeks and that the sale of products made by Maiden Pharmaceuticals has been banned. He said that some of the syrups were still being sold in private clinics and hospitals until recently.
Gambia's Medicines Control Agency sent a letter to health professionals on Tuesday ordering them to stop selling any of the products listed by WHO.
Maiden Pharmaceuticals makes medicines at its facilities in India and sells them domestically as well as exporting them to countries in Asia, Africa and Latin America, according to its website.