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.
Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup are products of an Indian company, Maiden Pharmaceuticals.
Sahpra and the World Health Organisation (WHO) had detected the products in The Gambia.
“Thirty-three children in the Gambia died of kidney-related illness. The WHO conducted laboratory tests that linked the medication to those deaths. The four products contain unacceptable amounts of diethylene glycol, which are toxic substances and can prove fatal,” said the regulator.
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.
“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.”
It added side-effects linked to the products, include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, alerted mental state, and acute kidney injury.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said the regulator would work with law enforcement to remove the products.
The WHO added the products might have been distributed to other countries illegally.
“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 or 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,” said the WHO.
Source: News24, The Citizen, Times Live, image from Twitter: @SAHPRA1