Probing Indian cough syrup after 66 children die in Gambia: WHO

New York, Oct 05: The World Health Organization (WHO) on Wednesday issued a medical product alert for four contaminated medicines made by Maiden Pharmaceuticals in India have been potentially linked with acute kidney injuries and 66 deaths among children.

The global health body said it 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. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," WHO said in a press release.

"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 The Gambia, but may have been distributed, through informal markets, to other countries or regions," the release added.

Risks

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal

Toxic effects 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.

Advice to regulatory authorities and the public

It is important to detect and remove these substandard products from circulation to prevent harm to patients.

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.

All medical products must be approved and obtained from authorized/licensed suppliers. The products' authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt.

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.

National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.