LONDON, April 19 (Reuters) - The World Health
Organization is likely to issue a wider warning about
contaminated Johnson and Johnson ( JNJ )-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 U.N. 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 ( KVUE ) now owns the brand
after a spin-off from J&J last year.
J&J has referred requests for comment to Kenvue ( KVUE ). In an
emailed statement on Friday, Kenvue ( KVUE ) 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 ( KVUE ) 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 ( KVUE ) spokesperson said on Friday.