'WHO' warns about four baby cough syrups may lead to death

The World Health Organization (WHO) has raised an alert over four cold, fever and cough syrups made by Maiden pharmaceutical company. All the four syrups are as follows "Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup". - Urging people not to use them.

“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in Gambia, but may have been distributed, through informal markets, to other countries or regions,” the WHO said in the alert.

All batches of the products “should be considered unsafe” till they are analysed by the respective national regulatory authorities and approved as safe to use.

According to sources, India’s apex drug regulatory authority – the Central Drugs Standard Control Organisation (CDSCO) – has already launched an investigation into the matter after it was informed about the issue on September end. The state regulatory authority of Haryana confirmed that the company did manufacture and export the syrups to Gambia. The company has so far sold the product only to Gambia. 

WHO Twitter handle in a post quoted its Director General Dr Tedros Adhanom Ghebreyesus as saying, “In India, death of 17 children were reported from Jammu and Kashmir in 2020 after consuming another brand of cough syrup contaminated with the same diethylene glycol. In another incident, at least three children died in New Delhi last year after consuming a cough syrup with dextromethorphan, one of the components present in one of the four syrups flagged by WHO".

Sources said four of the 23 samples tested by the WHO were found to be contaminated with diethylene glycol or ethylene glycol. However, the intra-government agency has not provided details to India on causal relation with the death or documents to show that the syrups led to the deaths.

Diethylene glycol and ethylene glycol can cause toxic effects, including abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury that may lead to death. “The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death,” the WHO alert said.

“If you have these substandard products, please do not use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre,” the WHO alert said.

The national authorities have been asked to report if any of these substandard products are discovered or distributed in their country.