The South African Health Products Regulatory Authority (SAHPRA) has issued a warning about health products linked to the 33 babies who died in The Gambia.
This comes after 33 children in The Gambia died of kidney-related illnesses after consuming cough syrup manufactured by an Indian company, Maiden Pharma.
However, according to international reports, 66 children have lost their lives.
“SAHPRA, like other regulators globally, has been alerted to dubious health products being traded by an Indian company, Maiden Pharmaceuticals,” the statement read on Monday.
The World Health Organisation (WHO) has since issued a global alert over the four cough syrups identified in The Gambia and reported to the organisation in September 2022.
According to the WHO, substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore “out of specification”.
“These products have been identified in The Gambia, but there is a possibility that these products may be distributed to other countries.”
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup manufactured by Maiden Pharmaceuticals.
According to SAHPRA these products are not registered for use in South Africa.
“The WHO conducted laboratory tests which 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 regulator said.
“The fact that these medicines were administered to children makes the matter far more serious.”
Toxic effects following the consumption of the products, according to SAHPRA, include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and 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 them to children.”
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, said the watchdog’s mandate is to ensure that the public has access to quality, safe and effective health products.
“The safety of the public is of paramount importance. Our Regulatory Compliance Unit will work with law enforcement agencies to eradicate any substandard and falsified health products,” she added.
SAHPRA urged citizens to contact their Regulatory Compliance Unit at Mokgadi.fafudi@sahpra.org.za if they have any information about these products.
