World Health Organization (WHO) alerts against Indian made cough syrups after 66 children died in Gambia. The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. WHO is conducting further investigation with the company and regulatory authorities in India.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Laboratory analysis of samples of each of the four products confirm that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Toxic effects diethylene glycol and ethylene glycol can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death. All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.
"While the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients" said, Dr. Tedros, Director General of the World Health Organization.
He further said, "WHO has today issued a medical product alert for four contaminated medicines identified in Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children. The loss of these young lives is beyond heartbreaking for their families."
WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised.
