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The deaths of dozens of young children in The Gambia from acute kidney injury may be linked to contaminated cough and cold syrups made by an Indian drug maker, the World Health Organization said on Wednesday.
The findings, announced by WHO Director-General Tedros Adhanom Ghebreyesus, followed tests on several medicinal syrups suspected of causing 66 child deaths in the tiny West African country.
Tedros told reporters that the UN agency was investigating with Indian regulators and the company that makes the syrups, New Delhi-based Maiden Pharmaceuticals Ltd.
Maiden Pharma declined to comment, while calls and messages to the Drug Controller General of India went unanswered.
The WHO issued a medical product alert on Wednesday asking regulators to remove Maiden Pharma’s products from the market.
The products may have been distributed elsewhere through informal markets, but so far they have only been traced to The Gambia, the WHO said in its warning.
The alert covers four products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Laboratory analysis confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, the WHO said.
Doctors in The Gambia raised the alarm in July after dozens of children began falling ill with kidney problems. The deaths puzzled doctors before a pattern emerged: dozens of patients under the age of five fell ill three to five days after taking a topical paracetamol syrup.
Gambia’s director of health services, Mustapha Bittaye, said similar problems had been detected in other syrups, but that the ministry was awaiting confirmation of the results.
He said the number of deaths had fallen in recent weeks and that the sale of products made by Maiden Pharmaceuticals had been banned. However, until recently, some of the syrups were still sold in private clinics and hospitals, he said.
The Gambia Drug Control Agency on Tuesday sent a letter to health professionals ordering them to stop selling any of the products listed to the WHO.
Maiden Pharmaceuticals manufactures drugs at its facilities in India, which it then sells domestically as well as exports to countries in Asia, Africa and Latin America, according to its website.
