Oct 5 (Reuters) – The deaths of dozens of young children from acute kidney injuries in Gambia may be linked to contaminated cough and cold syrups made by an Indian drugmaker, the World Health Organization said on Wednesday.
The findings, announced by WHO Director-General Tedros Adhanom Ghebreyesus, came after tests were carried out on several medicinal syrups suspected of being the cause. 66 child deaths in the small West African country.
Tedros told reporters that the UN agency was investigating Indian regulators and the company that makes the syrups, New Delhi-based Maiden Pharmaceuticals Ltd.
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Maiden Pharma declined to comment, while calls and messages to the Drug Controller General of India went unanswered. India’s health ministry did not respond to a request for comment.
The WHO issued a medical product alert on Wednesday asking Maiden Pharma to withdraw its products from the market.
The products may have been distributed elsewhere through informal markets, but have so far only been identified in The Gambia, the WHO said in a 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” levels of diethylene glycol and ethylene glycol, which can be toxic and cause acute kidney injury, the WHO said.
Gambian health workers raised the alarm in July after dozens of children started falling ill with kidney problems. The deaths baffled doctors before a pattern emerged: dozens of patients under the age of five fell ill three to five days after taking locally sold paracetamol syrup.
Gambia’s director of health services, Mustapha Bittaye, said similar problems had been detected in other sherbets, but the ministry was awaiting confirmation of the results.
He said the death toll had dropped in recent weeks and that products manufactured by Maiden Pharmaceuticals had been banned from sale. However, until recently, some of the syrups were still sold in private clinics and hospitals, he said.
Gambia’s Medicines Control Agency sent a letter to health officials on Tuesday ordering them to stop selling any of the products listed by the WHO.
Maiden Pharmaceuticals manufactures drugs at its facilities in India, then sells them locally, and also exports them to countries in Asia, Africa and Latin America.
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Reporting by Leroy Leo and Raghav Mahobe in Bengaluru, Jennifer Rigby and Edward McAllister in London Editing by Anil D’Silva, William Maclean and Matthew Lewis
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