Johannesburg - The South African Health Products Regulatory Authority (SAHPRA), like other regulators globally, said it was alerted to dubious health products being traded by an Indian company, Maiden Pharmaceuticals.
SAHPRA said the products, as they appear on the World Health Organization (WHO) product list, 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. The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup manufactured by Maiden Pharmaceuticals,” the regulatory authority said.
According to the WHO, 33 children in the Gambia died of kidney-related illnesses, and 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 fact that these medicines were administered to children makes the matter far more serious,” SAHPRA said.
The toxic effects following the consumption of the products can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.
Anyone in possession or who comes across any of these products has been urged to not consume these products, nor should you administer them to children.
“SAHPRA’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,” said SAHPRA chief executive Dr Boitumelo Semete-Makokotlela.
The Star