SAHPRA on Benylin Paediatric Cough Syrup
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By Thabo Mosia – The South African Health Products Regulatory Authority (SAHPRA) has announced that comprehensive testing has revealed no traces of diethylene glycol in Benylin paediatric cough syrup. This comes after two batches of the product were recalled in April due to safety alerts from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC).
Understanding the Recall
NAFDAC had raised alarms over high levels of diethylene glycol — a potentially fatal substance when ingested. Symptoms of diethylene glycol poisoning include abdominal pain, vomiting, diarrhoea, difficulty in urinating, headache, altered mental state, and acute kidney injury, all of which can be life-threatening.
“The recall was implemented as a precaution to protect lives, while SAHPRA investigated the reported high levels of diethylene glycol,” stated the local drug watchdog.
Investigative Measures and Findings
As South Africa’s primary regulatory authority for health products, SAHPRA prioritises public safety and swiftly responded to NAFDAC’s concerns. They subjected the affected batches — 329303 and 329304 — to rigorous testing.
“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 for testing products for the presence of diethylene glycol. The tests did not find traces of diethylene glycol in the recalled batches,” SAHPRA confirmed in their statement.
The testing process, conducted at prescribed storage temperatures, revealed no presence of the toxin, ensuring that the products were safe for consumption.
No Adverse Reactions Recorded
Besides these constructive findings, SAHPRA also assured the public that there had been no reports of adverse drug reactions linked to diethylene glycol from the two recalled batches. This holds true both within South Africa and other African nations where these batches were exported.
Upholding Public Health Standards
SAHPRA’s mandate extends beyond this isolated incident, encompassing the regulation and quality assurance of all health products in South Africa. The authority rigorously applies due diligence throughout the product lifecycle — from initial registration to post-market surveillance.
“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,” confirmed SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
Comprehensive Oversight
SAHPRA’s responsibilities include the regulation, monitoring, evaluation, investigation, inspection, and registration of all health products. This spans clinical trials, complementary medicines, medical devices, in-vitro diagnostics (IVDs), and oversight of radiation control.
Through such comprehensive measures, SAHPRA ensures that health products meet the highest safety and quality standards, reinforcing public trust in the medicines available in South Africa.
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