SAHPRA Clears Benylin Paediatric Cough Syrup of Toxic Compound

The authority remains committed to its mandate of ensuring that all health products available in South Africa are safe and of high quality.

The South African Health Products Regulatory Authority (SAHPRA) has confirmed that no traces of diethylene glycol were found in the Benylin paediatric cough syrup. This follows the precautionary recall of two batches in April after concerns were raised by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC).

Key Findings:

No Diethylene Glycol Detected: SAHPRA's investigation, which included testing samples of the affected batches through an independent laboratory using a WHO-developed method, found no traces of the toxic compound in the recalled batches (329303 and 329304).

Reason for Recall: The recall was initially implemented as a precautionary measure to protect public health while the reported high levels of diethylene glycol were being investigated.

Health Risks of Diethylene Glycol: Diethylene glycol is toxic to humans, and its ingestion can cause severe health issues, including abdominal pain, vomiting, diarrhoea, headache, altered mental state, acute kidney injury, and potentially death.

SAHPRA’s Responsibilities and Actions:

Product Testing and Monitoring: SAHPRA ensures the safety and quality of health products through stringent regulatory processes from registration to post-market monitoring. This includes independent testing for contaminants like diethylene glycol.

Safety and Compliance: SAHPRA emphasized that there have been no reports of adverse drug reactions related to diethylene glycol from the two recalled batches, either in South Africa or other African countries where the products were exported.

Continued Vigilance: SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, reassured that the authority will continue to monitor medical products for potential safety and quality issues to protect public health.

Role of SAHPRA:

SAHPRA is responsible for regulating health products, which includes monitoring, evaluating, investigating, inspecting, and registering various health-related items such as clinical trials, complementary medicines, medical devices, and in-vitro diagnostics. Additionally, it oversees radiation control in South Africa.

Conclusion:

SAHPRA’s rigorous testing and monitoring processes have cleared Benylin paediatric cough syrup of any harmful levels of diethylene glycol, reaffirming the safety of the product for public use. The authority remains committed to its mandate of ensuring that all health products available in South Africa are safe and of high quality.