SAHPRA warns against contaminated medicine linked to 33 child deaths

The contaminated products contain “unacceptable amounts” of substances toxic to humans that can prove to be fatal, said the WHO.

Oct 11, 2022 - 10:18
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SAHPRA warns against contaminated medicine linked to 33 child deaths

Four health products distributed by an Indian company have been linked to the deaths of 33 children in The Gambia. The products are not registered for use in South Africa; however, the local health products authority (SAHPRA) has been alerted to the dubious products by the World Health Organization (WHO).

MEDICINE CONTAINS ‘UNACCEPTABLE AMOUNTS’ OF TOXIC SUBSTANCES

SAHPRA said the contaminated products are distributed by Maiden Pharmaceuticals and identified as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup in the WHO product list.

READ: SAHPRA confirms second vaccine-linked death in SA

The products have been identified in The Gambia but there is a possibility that they may have been distributed to other countries.

In The Gambia, 33 children have died of kidney-related illness. The WHO’s laboratory tests have linked the contaminated medicine to those fatalities.

The contaminated products contain unacceptable amounts of diethylene glycol and ethylene glycol – The WHO said these substances are toxic to humans and can prove to be fatal. The symptoms of consumption include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

Promethazine Oral Solution and Kofexmalin Baby Cough Syrup. Images: WHO.
Makoff Baby Cough Syrup and Magrip N Cold Syrup. Images: WHO.

SAHPRA SAYS PUBLIC SAFETY IS OF PARAMOUNT IMPORTANCE

SAHPRA said the matter is “more serious” because the contaminated medicines were given 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 CEO, Dr Boitumelo Semete-Makokotlela.

If members of the public are in possession of the mentioned medicines, they are advised not to consume them or administer it to children. Such incidents can be reported to the Regulatory Compliance Unit at Mokgadi.fafudi@sahpra.org.za / 012-015-5434.

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