WHO likely to issue wider alert on contaminated Johnson & Johnson cough syrup

The World Health Organization is likely to issue a wider warning about contaminated Johnson and Johnson-made children's cough syrup found in Nigeria last week, it said in an email. Nigeria's regulator recalled a batch of Benylin paediatric syrup last Wednesday, having found a high level of diethylene glycol in the product during routine testing.

The contaminant, alongside another closely related toxin, ethylene glycol, has been linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia and Uzbekistan since 2022, though there is no evidence that these incidents are linked with the latest recalls.

The UN health body said it puts out global medical product alerts to "encourage diligence" by national authorities and was likely to do so in this instance, "subject to confirmation of certain details from parties".

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

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

"We continue to work closely with health authorities and the WHO and are engaging with NAFDAC to understand their test results, including verifying the authenticity of the sampled product, the testing methodology used, and results reported by the agency," the statement added.
Since Nigeria's recall, five other African countries have also pulled the product from shelves - Kenya, Rwanda, Tanzania, Zimbabwe and South Africa, where the drug was made.

South Africa’s 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 result in acute kidney failure, although there have been no reports of harm in the latest incident.

RAW MATERIALS

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 collaborating with both the manufacturer and regulatory authority in South Africa to investigate the Benylin paediatric syrup, and had information on the source of the ingredients used. Kenvue has previously said it tested its ingredients before manufacture.

The agency said the possibility that the syrup was counterfeit was also "under consideration as part of investigations".

Earlier this week the WHO sent out a separate alert on five batches of contaminated cough syrup ingredients found in Pakistan that appeared to have been falsely labelled as Dow Chemical products.

It was the first alert the WHO has sent on excipients - elements of a medicine 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 alert manufacturers that may have been procuring this material to exercise more caution," a WHO spokesperson said by email.

Propylene glycol is not an ingredient in Benylin paediatric syrup, a Kenvue spokesperson said on Friday.