The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has confirmed that there are no recorded cases of death or illness in children due to a batch of Benylin Paediatric cough syrup that was recently recalled. This announcement comes after heightened safety measures were implemented following the discovery of harmful levels of diethylene glycol in the syrup, a substance known for its potential toxicity.
The recall, which took place last week, was a preventive measure taken by NAFDAC after laboratory tests revealed the presence of diethylene glycol exceeding acceptable limits. This finding prompted similar recalls in five other African countries including Kenya, South Africa, Tanzania, Rwanda, and Zimbabwe. South Africa went a step further by recalling an additional batch of the syrup.
Fraden Bitrus, NAFDAC’s Director of Pharmacovigilance, emphasized that the decision to conduct these tests and subsequent recall was influenced by recent tragic incidents in other parts of Africa, where contaminated medications had led to multiple child fatalities. He clarified that the proactive testing was not triggered by specific reports of adverse effects from the cough syrup in Nigeria but was rather a part of a broader safety campaign.
“We sampled several products following the incidents in other African countries. While some passed the tests, others did not meet our safety standards. Initially, we did not test for diethylene glycol, but given the recent concerns, we re-evaluated the products for this chemical,” Bitrus explained.
Diethylene glycol poisoning can lead to acute kidney injury and has been associated with numerous deaths in cases across Gambia, Uzbekistan, and Cameroon since 2022, marking one of the worst global incidents of medicinal poisoning.
The specific batch of Benylin Paediatric syrup in question was manufactured in South Africa by Johnson & Johnson in May 2021, before the brand was acquired by Kenvue following a spin-off from J&J last year. When asked about the involvement of both companies in addressing the issue, Joe Wolk, J&J’s Chief Financial Officer, stated that the matter is currently being handled by Kenvue.
Kenvue has acknowledged the severity of the situation and is actively conducting an assessment. The company is working closely with health authorities to determine the necessary steps to ensure consumer safety and prevent similar incidents in the future.
As countries around Africa implement recalls and increase vigilance regarding imported medications, NAFDAC’s actions emphasize the importance of stringent regulatory oversight in preventing health crises. The agency continues to monitor the situation closely, ensuring that all pharmaceutical products in Nigeria meet the required safety standards to protect public health.
