No traces of toxic compound found in paediatric cough syrup

The South African Health Products Regulatory Authority (SAHPRA) says it has found no traces of diethylene glycol in the Benylin paediatric cough syrup.

This comes after SAHPRA recalled two batches of the cough syrup in April after the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) raised concerns about the medicine containing high levels of diethylene glycol.

Ethylene glycol is toxic to humans when consumed and can prove fatal.

The effects include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury that may lead to death.

The recall was implemented as a precaution to protect lives, while SAHPRA investigated the reported high levels of diethylene glycol, SAHPRA said in a statement. As the national regulatory authority for health products, SAHPRA may recall health products as a crucial measure to address safety concerns and quality issues in the interest of public health.

“As part of the investigation of the reported high levels of diethylene glycol, SAHPRA tested samples of the two affected batches of Benylin paediatric syrup through an independent laboratory and a method developed by the World Health Organisation (WHO) for testing products for the presence of diethylene glycol. The tests did not find traces of diethylene glycol in the recalled batches,” the statement read.

“This indicates that units of batches 329303 and 329304, that were stored at the required temperature, would not contain unacceptable levels of diethylene glycol.”

SAHPRA also indicated that there was no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in South Africa or anywhere else where they were exported in Africa.

However, they are mandated to regulate and apply due diligence to health products to ensure that products in circulation in South Africa and those exported from SAHPRA-licensed manufacturers are safe for public consumption, said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

SAHPRA applies this due diligence throughout the product life cycle, from registration through to post-market monitoring, Dr Semete-Makokotlela added.

“SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected,” said Dr Semete-Makokotlela.

SAHPRA is tasked with regulating – monitoring, evaluating, investigating, inspecting and registering – all health products. This includes clinical trials, complementary medicines, medical devices and in-vitro diagnostics (IVDs) and overseeing radiation control in South Africa.