AFRICA: The World Health Organization (WHO) issued a warning on Wednesday about four cough and cold syrups made by Maiden Pharmaceuticals in India, warning that they may be linked to the deaths of 66 children in the Gambia.
The UN health agency also warned that the contaminated drugs may have been distributed outside the West African country, with global exposure “possible”.
WHO chief Tedros Adhanom Ghebreyesus told reporters that the four cold and cough syrups “were potentially linked to acute kidney injury and 66 deaths in children.”
“The loss of these young lives is beyond heartbreaking for their families.”
Tedros said the WHO is also “conducting further investigations with the company and regulatory authorities in India”.
The four products are Promethazine Oral Solution, Kofexmalin Children’s Cough Syrup, Makoff Cough Syrup and Magrip N Cold Syrup, according to a drug alert issued by the WHO on Wednesday.
“The said manufacturer has not yet provided WHO with assurances on the safety and quality of these products,” the alert said, adding that laboratory analysis of product samples “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”
The substances are toxic to humans and can be fatal, the agency said, adding that toxic effects, “may include abdominal pain, vomiting, diarrhoea, inability to urinate, headache, altered mental status, and acute kidney injury that may lead to death.”
Gambia’s health ministry last month asked hospitals to stop using paracetamol syrup as it awaits the outcome of an investigation after at least 28 children died of kidney failure.
The WHO said information received from India’s Central Drugs Standard Control Organization indicated that the manufacturer had only supplied the contaminated drugs to The Gambia.
“However, the supply of these products through informal or unregulated markets to other countries in Africa cannot be ruled out,” the UN agency said in an email.
“Furthermore, the manufacturer may have used the same contaminated material in other products and distributed them locally or exported them,” it warned. “Global exposure is therefore possible.”
Tedros urged caution and urged all countries to work to “detect and remove these products from circulation to prevent further harm to patients.”
The Gambian Ministry of Health’s advisory on paracetamol syrup was issued on September 9, a month after investigators reported the deaths of at least 28 children between the ages of five months and four years from acute kidney failure.
The investigation was opened on July 19. No details about when the children died were provided.