The South African Health Products Regulatory Authority (Sahpra) has warned the public to refrain from giving their children “dubious” health products that have been linked to the deaths of 33 babies in The Gambia.
According to Sahpra, the four health products being traded by an Indian company, Maiden Pharmaceuticals, are not registered for use in South Africa.
“These products have been identified in The Gambia, but there is a possibility that these products may be distributed to other countries,” said Sahpra on Monday.
The four products are:
- Promethazine Oral Solution
- Kofexmalin Baby Cough Syrup
- Makoff Baby Cough Syrup
- Magrip N Cold Syrup
According to Sahpra, 33 children in The Gambia died of kidney-related illness and laboratory tests conducted by the World Health Organisation (WHO) linked the medication to those deaths.
“The four products contain unacceptable amounts of diethylene glycol and ethylene glycol which are toxic substances and can prove to be fatal. The fact that these medicines were administered to children makes the matter far more serious,” said Sahpra.
The WHO sent the initial alert on 5 October, calling on parents to stop feeding their babies the health products, after the manufacturer failed to provide guarantee on the safety and quality of the products.
“All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulatory Authorities,” said the WHO last week.
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“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.”
Toxic effects following consumption of the product(s) include:
- Abdominal pain
- Vomiting
- Diarrhoea
- Inability to pass urine
- Headache
- Altered mental state
- Acute kidney injury which may lead to death
“If you are in possession or come across any of these products, please ensure that you do not
consume these products, nor should you administer it to children. If you know of such
instances, please contact our Regulatory Compliance unit.”
