The WHO on Wednesday issued an alert that four cough and cold syrups produced by India’s Maiden Pharmaceuticals may have killed 66 children in The Gambia and have been distributed in other countries.
It was the Director General of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus, who himself announced the “Medical Product Alert” during his weekly press conference on global health issues.
The contaminated drugs are cough and cold syrups which “may be linked to acute kidney injury and the death of 66 children”, he said.
These are four products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. They are all manufactured by the same company Maiden Pharmaceuticals Limited.
“Furthermore, the manufacturer might have used the same contaminated material in other products and distributed them locally or exported them. A global risk is therefore possible,” warned the WHO.
“WHO is investigating with the company and regulators in India,” Dr Tedros said.
In the technical document of the alert, the WHO indicates that “laboratory analysis of samples of each of the four products confirms contamination by diethylene glycol and ethylene glycol in unacceptable quantities”.
Diethylene glycol and ethylene glycol are toxic and can be fatal.
Toxic effects include – according to the WHO – abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status and acute kidney damage that can lead to death.
The Geneva-based organization says the four contaminated drugs were identified in The Gambia, but may have been distributed through informal markets elsewhere in Africa.
“All batches of these products must be considered unsafe until they can be analyzed by the competent National Regulatory Authorities”, indicates the WHO.
As a precautionary measure, the WHO recommends that all countries detect and remove these drugs from circulation.
On September 9, Gambian health authorities said they had opened an investigation in mid-July into the recent deaths of 28 children, some of whom were between five months and four years old, from acute kidney failure. They had asked hospitals and clinics to no longer use paracetamol syrup.
Authorities had also cited E. coli bacteria as possible causes.
But on September 23, health authorities in The Gambia ordered the recall of all medicines containing paracetamol or promethazine syrup.
Gambian health authorities began operations on Wednesday to recover the products. Agents went door to door in homes in rural areas, they told an AFP correspondent.
The recall should also apply to importers, wholesalers and retailers of drugs, including hospitals.
The Gambia, the smallest country in mainland Africa with just over two million inhabitants, is 174th out of 191 on the UN’s human development index, which aggregates criteria of health, education and level of life.
Nearly half of the population there lives below the poverty line, according to the World Bank.