NAFDAC, Head Quarters
April 17, 2024
Nigeria’s drug regulator has no record of children dying or falling ill from exposure to a batch of cough syrup made by Johnson & Johnson in South Africa that was recalled last week, a senior official said on Tuesday.
Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) announced the recall after laboratory tests found an unacceptably high level of diethylene glycol, which is toxic to humans, prompting regulators in five other African countries to also issue recalls.
South Africa’s drug regulator said on Tuesday that there was no record of adverse reactions in South Africa or anywhere in the world to the two batches of Benylin Paediatric Syrup it recalled.
It said it was conducting tests and investigations, as was manufacturer Kenvue which now owns the brand after a spin-off from J&J last year.
“We hope to finalise these soon,” the South African Health Products Regulatory Authority told Reuters.
Consuming diethylene glycol can result in acute kidney failure. The substance has been linked to 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.
Fraden Bitrus, NAFDAC’s director of pharmacovigilance, told Reuters the regulator had been testing cough syrups in response to those deaths, not because of any specific report of harm to children in Nigeria.
The recalled batches of syrup were made by J&J in South Africa in May 2021.
Asked whether J&J was working with Kenvue to investigate what had gone wrong, Joe Wolk, chief financial officer of J&J, told Reuters: “This is just with Kenvue at this point.”
Kenvue has said it is working with health authorities to determine next steps.
In addition to Nigeria and South Africa, regulators in Kenya, Tanzania, Rwanda and Zimbabwe have recalled the same batch of Benylin Paediatric Syrup.
REUTERS
