WHO warns against Maiden Pharma's four cough syrups for children

Oct 06, 2022, 05:00 pm

The World Health Organization (WHO) on October 5 issued a medical product alert on four contaminated medicines in Gambia. It has identified that the products have been potentially linked to acute kidney injuries and 66 deaths among children.


According to WHO, the four medicines are cough and cold syrups produced by Maiden Pharmaceuticals in India. The global body said it is conducting further investigation with the company and Indian regulatory authorities.


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WHO Director-General Tedros Adhanom Ghebreyesus at the media briefing said, "WHO has today issued a medical product alert for four contaminated medicines identified in The 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. The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India."


The four substandard (contaminated) paediatric medicines identified by the WHO are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.


Reuters has reported that Maiden Pharma declined to comment on the alert, while calls and its messages to the Drugs Controller General of India went unanswered. The news agency also said Gambia and India's health ministry also did not immediately respond to a request for comment.


The organization said the manufacturer has not provided guarantees to WHO on the safety and quality of these products.


The WHO also said in its report that the laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.


It has further added that to date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.


Issuing an alert about the risks from using these medicines, the WHO said Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.


The WHO in its advice to regulatory authorities and the public mentioned that it is important to detect and remove these substandard products from circulation to prevent harm to patients.

It has requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products.

Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore "out of specification".