Nigeria’s Drug Regulator Finds No Record of Adverse Reactions to Recalled Cough Syrup


Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) stated that it has no documented cases of children experiencing illness or fatalities due to exposure to a batch of cough syrup manufactured by Johnson & Johnson in South Africa, which was recalled last week. The recall was prompted by laboratory tests revealing elevated levels of diethylene glycol, a toxic substance harmful to humans, leading regulatory bodies in five other African nations to also issue recalls.

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South Africa’s drug regulatory authority reported no adverse reactions linked to the recalled Benylin Paediatric Syrup batches, neither domestically nor internationally. The manufacturer, Kenvue, which acquired the brand after its spin-off from J&J last year, is collaborating with authorities to conduct tests and investigations to identify the root cause.

Diethylene glycol ingestion can lead to acute kidney failure and has been associated with numerous child fatalities in countries like Gambia, Uzbekistan, and Cameroon since 2022, marking one of the worst incidents of oral medication poisoning globally.

Fraden Bitrus, NAFDAC’s director of pharmacovigilance, clarified that the agency initiated testing on cough syrups following reports of child fatalities, rather than specific reports of harm in Nigeria. While some products passed the tests, others failed, prompting a closer examination of the recalled batch manufactured by J&J in South Africa in May 2021.

Joe Wolk, chief financial officer of J&J, indicated that investigations are primarily conducted with Kenvue at this stage. Kenvue, in collaboration with health authorities, is actively determining the necessary steps moving forward.

Beyond Nigeria and South Africa, regulators in Kenya, Tanzania, Rwanda, and Zimbabwe have also recalled the same batch of Benylin Paediatric Syrup, emphasizing the collective concern for public health and safety across the region.

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