LONDON –
The World Well being Group is more likely to challenge a wider warning about contaminated Johnson and Johnson-made youngsters’s cough syrup present in Nigeria final week, it mentioned in an e-mail.
Nigeria’s regulator recalled a batch of Benylin pediatric syrup final Wednesday, having discovered a excessive stage of diethylene glycol within the product throughout routine testing.
The contaminant, alongside one other intently associated toxin, ethylene glycol, has been linked to the deaths of greater than 300 youngsters in Cameroon, Gambia, Indonesia and Uzbekistan since 2022, although there is no such thing as a proof that these incidents are linked with the newest recollects.
The UN well being physique mentioned it places out international medical product alerts to “encourage diligence” by nationwide authorities and was doubtless to take action on this occasion, “topic to affirmation of sure particulars from events.”
The recalled batch of Benylin syrup was made by J&J in South Africa in Might 2021, though Kenvue now owns the model after a spin-off from J&J final 12 months.
J&J has referred requests for remark to Kenvue. In an emailed assertion on Friday, Kenvue mentioned it had carried out checks on the batch recalled by Nigeria and had not detected both diethylene or ethylene glycol.
“We proceed to work intently with well being authorities and the WHO and are partaking with NAFDAC to grasp their check outcomes, together with verifying the authenticity of the sampled product, the testing methodology used, and outcomes reported by the company,” the assertion added.
Since Nigeria’s recall, 5 different African nations have additionally pulled the product from cabinets – Kenya, Rwanda, Tanzania, Zimbabwe and South Africa, the place the drug was made.
South Africa’s regulator has additionally recalled one other batch of the syrup, which is used to deal with coughs, hay fever and different allergic reactions in youngsters.
Diethylene glycol is poisonous to people when consumed and may end up in acute kidney failure, though there have been no experiences of hurt within the newest incident.
Uncooked supplies
Within the 2022 circumstances, the contamination within the syrups got here from the uncooked supplies utilized by producers in India and Indonesia.
The WHO mentioned it was collaborating with each the producer and regulatory authority in South Africa to analyze the Benylin pediatric syrup, and had info on the supply of the elements used. Kenvue has beforehand mentioned it examined its elements earlier than manufacture.
The company mentioned the chance that the syrup was counterfeit was additionally “into consideration as a part of investigations.”
Earlier this week the WHO despatched out a separate alert on 5 batches of contaminated cough syrup elements present in Pakistan that appeared to have been falsely labeled as Dow Chemical merchandise.
It was the primary alert the WHO has despatched on excipients – parts of a medication apart from the energetic pharmaceutical ingredient – moderately than completed merchandise, the company confirmed on Friday.
The batches of propylene glycol had been contaminated with ethylene glycol.
“It was important for WHO to additionally alert producers that will have been procuring this materials to train extra warning,” a WHO spokesperson mentioned by e-mail.
Propylene glycol is just not an ingredient in Benylin pediatric syrup, a Kenvue spokesperson mentioned on Friday.
(Reporting by Jennifer Rigby; extra reporting by Patrick Wingrove. Modifying by Jan Harvey and Barbara Lewis)
