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WHO alerts West Africa to four “substandard” pediatric drugs made in India

By amfnews Oct 6, 2022 #Featured
WHO alerts West Africa to four "substandard" paediatric drugs made in India_AMF NEWSWHO alerts West Africa to four "substandard" paediatric drugs made in India_AMF NEWS
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The World Health Organization issued an alert on Wednesday regarding four “contaminated” drugs, mostly for paediatric use, that were discovered in the west African country of The Gambia and were later determined to contain hazardous and potentially lethal ingredients.

According to a WHO Medical Product Alert, the four subpar products that were reported to the organisation in September are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. It is claimed that Maiden Pharmaceuticals Ltd, a company based in Haryana, manufactures all four of these products.

The alert noted that laboratory analysis of samples of each of the four products confirms that they contain unacceptable levels of diethylene glycol and ethylene glycol, both of which are “toxic to humans when consumed and can prove fatal,” noting that the stated manufacturer has not given guarantees to WHO on the safety and quality of these products.

The warning stated, “The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.” It went on to say that the toxic effects can include abdominal pain, vomiting, diarrhoea, the inability to pass urine, headaches, altered mental status, and acute kidney injury, which may result in death.

All of these product batches should be regarded as hazardous until they can be examined by the appropriate national

The WHO advised that up until they can be examined by the appropriate national regulatory agencies, all batches of these items should be regarded as dangerous.

Although these four goods have been discovered in The Gambia, it is suspected that they have also been transferred through unofficial marketplaces to other nations or regions. It is crucial to find and remove these subpar products from circulation in order to protect patients.

WHO asks that supply chains in the nations and areas most likely to be impacted by these items be subjected to heightened scrutiny and attention. The notice also recommended increased monitoring of the unofficial/unregulated market.

The legitimacy and physical condition of the products should be thoroughly examined, and when in question, help from a healthcare professional should be sought. It was also emphasised that all medical products must be approved and purchased from authorized/licensed vendors.

“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 warning read.

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

By amfnews

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