HQ Team
April 17, 2024: Drug regulatory authorities in South Africa, Tanzania, Rwanda, Nigeria, Kenya, Eswatini and Zimbabwe have issued a recall for a batch of Benylin Pediatric, a children’s cough syrup made by Johnson & Johnson (J&J), after Nigeria’s drug regulator found elevated levels of toxicity in tests.
The National Agency for Food and Drug Administration and Control, NAFDAC, Nigeria, announced the recall after laboratory tests found an unacceptably high level of diethylene glycol, a potentially toxic substance in the samples. According to the Nigerian regulator’s report, “laboratory analysis conducted on the product showed that it contains an unacceptable high level of diethylene glycol and was found to cause acute oral toxicity in laboratory animals.”
The Director of Pharmacovigilance, NAFDAC, Fraden Bitrus, explained that recent child deaths in other African countries linked to contaminated medication prompted increased cough syrup testing and not because of any specific report of harm to children in Nigeria.
“We sampled several products. Some failed and some passed. This particular product had been sampled earlier but we were not thinking of diethylene glycol and because of this, we decided to test the product again,” he said.
The Nigerian authorities have made it clear that no deaths related to the consumption of the medicine have been reported yet and the tests were done for a more vigilant approach to the ingredients following reported cases of deaths from contaminated cough syrups earlier.
Consumption of Diethylene glycol can result in acute kidney injury, abdominal pain, urinary infection and in some cases can prove fatal. The substance has been linked to the deaths of dozens of children in Gambia, Uzbekistan, and Cameroon since 2022 in one of the world’s worst waves of poisoning from oral medication.
J&J manufactured the batch being recalled in South Africa in May 2021, it carries an expiration date of April 2024, according to the Kenyan Pharmacy and Poisons Board (PPB).
Kenvue owns the Benylin brand after a spin-off from J&J last year. J&J has made it clear that the matter now rests with Kenvue.
Kenvue has said it was conducting its assessment and working with health authorities to determine the next steps
