Geneva: The World Health Organization issued a warning on Wednesday about four “contaminated” medicines manufactured in India, mainly for pediatric use, identified in the West African nation of The Gambia and found to contain chemicals that are toxic and potentially fatal after 66 children died .
“Today, WHO issued a medical product alert for four contaminated drugs identified in #Gambia that are potentially linked to acute kidney injury and 66 deaths among children. The loss of these young lives is beyond heartbreaking for their families,” the WHO said in a series of tweets, citing its Director-General Tedros Adhanom Ghebreyesus.
“The four medicines are cough and cold syrups manufactured by Maiden Pharmaceuticals Limited in India. WHO is conducting further investigation with the company and regulatory authorities in India,” the statement said.
The WHO’s medical product alert said the four substandard products reported to it in September were Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all of which are manufactured by Maiden Pharmaceuticals Ltd, which in Haryana.
Noting that the named manufacturer has not provided the WHO with assurances about the safety and quality of these products, the warning said that laboratory analysis of samples of each of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol, both ” toxic to humans when consumed and may prove fatal”.
“The substandard products referred to in this warning are not safe and their use, especially by children, may result in serious injury or death,” the statement said, adding that toxic effects may include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status and acute kidney injury, which can lead to death.
All batches of these products should be considered unsafe until they have been analyzed by the relevant national regulatory authorities, the WHO said.
Although these four products were identified in The Gambia, it was found that they may have been distributed through unofficial markets in other countries or regions and it is “important to detect and remove these substandard products from circulation to prevent harm to patients “.
WHO requires increased surveillance and diligence in the supply chains of countries and regions likely to be affected by these products. Enhanced surveillance of the informal/unregulated market is also recommended, the warning said.
It emphasizes that all medical products must be approved and obtained from authorized/licensed suppliers, the authenticity and physical condition of the products must be carefully checked and medical advice sought if in doubt.
“If you have these substandard products, please DO NOT use them. If you or someone you know has used these products or experienced an adverse reaction/event following use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or the National Pharmacovigilance Centre,” the warning says.
“National regulatory/health authorities are advised to immediately notify WHO if these substandard products are found in their respective country,” it added.