The deaths of 66 children in the Gambia may be linked to four cough and cold syrups made by Maiden Pharmaceuticals in India, according to a World Health Organization (WHO) alert, which also warned that contaminated medications may have been sent and distributed outside The Gambia - leading to fears of possible global exposure.

WHO chief Tedros Adhanom Ghebreyesus stated that the medications “have been potentially linked with acute kidney injuries and 66 deaths among children." While WHO was investigating the company and regulations in India, Tedros expressed, “The loss of these young lives is beyond heartbreaking for their families.” 

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

A Gambian Health Ministry investigation also declared that the acute kidney failure outbreak could be a result of the E. coli bacteria, which broke out in July and is still ongoing. On September 23, health authorities recalled all medicines containing paracetamol or promethazine syrup. The bacteria was discovered in the stools of many children, but many of them also took paracetamol syrup, adding more suspicion to the cause of death.

“The preliminary results from the ongoing investigation indicate that it is most probably the paracetamol and promethazine syrups that caused the acute kidney injury cases in this outbreak,” the nephrologist leading the health ministry’s investigation, Abubacarr Jagne, told AFP Wednesday.

In September, the Ministry released a statement, “Since July 2022, there has been an increase in the number of severe kidney disease with high fatality among children mainly following diarrheal diseases". 

The WHO alert said, “To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” adding that the lab analysis of the products' samples “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants."

The substances mentioned by the WHO are considered to be fatal, while the toxic effect “can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death."

When contacted by Reuters, Maiden Pharma declined to comment and the Drugs Controller General of India did not respond, and nor did India’s Health Ministry. However, WHO declared that information received from India’s Central Drugs Standard Control Organisation pointed to the fact that The Gambia was the only country that the manufacturer provided the medications to. 

“However, the supply of these products through informal or unregulated markets to other countries in Africa, cannot be ruled out,” WHO said in an email, warning, “In addition, the manufacturer may have used the same contaminated material in other products and distributed them locally or exported" - reiterating that global exposure could potentially happen.

Tedros further called for caution by urging countries to make an effort to “detect and remove these products from circulation to prevent further harm to patients."

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