The WHO is likely to issue a broader warning about contaminated J&J cough syrup – Asia Pacific

Nigeria’s regulator last Wednesday recalled a batch of Benylin children’s syrup after finding high levels of diethylene glycol in the product during routine testing.

The pollutant, along with another closely related poison, ethylene glycol, has been linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia and Uzbekistan since 2022, although there is no evidence linking these incidents to the latter recalls.

The UN health agency said it is issuing global warnings on medical products to “encourage due diligence by national authorities” and that this would likely happen in this case, “subject to confirmation of certain details from the parties”.

The recalled batch of Benylin syrup was made by J&J in South Africa in May 2021, although Kenvue now owns the brand following a spin-off from J&J last year.

J&J referred requests for comment to Kenvue. In an emailed statement on Friday, Kenvue said it had conducted tests on the batch recalled by Nigeria and had not detected any diethylene or ethylene glycol.

“We continue to work closely with health authorities and WHO and are working with NAFDAC to understand their testing results, including verifying the authenticity of the product sampled, the testing methodology used and the results reported by the agency,” the statement said.

Since Nigeria’s recall, five other African countries have also removed the product from their shelves: Kenya, Rwanda, Tanzania, Zimbabwe and South Africa, where the drug was made.

The South African regulator has also recalled another batch of the syrup, which is used to treat coughs, hay fever and other allergic reactions in children.

Diethylene glycol is toxic to humans when consumed and can lead to acute kidney failure, although there have been no reports of harm in the latest incident.

In the 2022 cases, the contamination in the syrups came from the raw materials used by manufacturers in India and Indonesia.

The WHO said it was working with both the manufacturer and the regulator in South Africa to investigate the Benylin children’s syrup, and had information on the source of the ingredients used. Kenvue has previously said it tested the ingredients before production.

The agency said the possibility that the syrup was counterfeit was also “being considered as part of investigations.”

Earlier this week, the WHO sent a separate alert about five batches of contaminated cough syrup ingredients found in Pakistan that appeared to be incorrectly labeled as Dow Chemical products.

It was the first warning the WHO has sent about excipients – elements of a drug other than the active pharmaceutical ingredient – ​​rather than finished products, the agency confirmed on Friday.

The batches of propylene glycol were contaminated with ethylene glycol.

“It was critical for WHO to also warn manufacturers who may have purchased this material to exercise greater caution,” a WHO spokesperson said by email.

Propylene glycol is not an ingredient in Benylin children’s syrup, a Kenvue spokesperson said Friday.