WHO may Issue a Larger Alert on Contaminated Kenvue Cough Syrup

The World Health Organization (WHO) is considering issuing a wider warning concerning a contaminated cough syrup for children made by Kenvue, according to an email sent by the agency. The contaminated cough syrup was found in Nigeria last week. 

Health regulators in Nigeria issued a recall order for a batch of Benylin pediatric syrup last Wednesday after they found a high level of diethylene glycol in the product during a routine test. Diethylene glycol and ethylene glycol are both toxic contaminants that led to the death of over 300 children in Gambia, Cameroon, Uzbekistan, and Indonesia since 2022. When consumed, the compound can lead to acute kidney failure. No casualties have been reported in the latest incident.

There is no evidence that the past events are related to the latest recalls. The WHO said the reason why it puts out global medical product alerts is to “encourage diligence” among national authorities and would likely do so in the current situation, “subject to confirmation of certain details from parties”.

The contaminated cough syrup was made in South Africa

Johnson and Johnson made the batch of the contaminated Benylin syrup in South Africa in May 2021. However, that brand is now owned by Kenvue which broke out from J&J last year. J&J is now directing every request for comment to Kenvue. In a statement emailed on Friday, April 19, 2024, Kenvue claimed that it tested the batch recalled by Nigeria and found no trace of ethylene or diethylene 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,” read the statement.

Following the recall by Nigerian health regulators last week, five other African countries have also recalled the product including Zimbabwe, Tanzania, Rwanda, Kenya, and South Africa (where the drug is manufactured). Regulators in South Africa have also recalled another batch of syrup used to treat cough, hay fever, and allergic reactions in children.

The previous case was traced to contaminants from raw materials

In 2022 when the last incident occurred, the contaminant was tranced to the raw materials used in the production of the cough syrup by the Indian and Indonesian manufacturers. The WHO said it is working with regulators and the manufacturer to investigate the Benylin cough syrup including information on the source of the ingredients.

Kenvue previously claimed that it tests its ingredients before manufacturing. As part of its investigation, the WHO is also considering the possibility that the cough syrup was counterfeited. 

Earlier this week, the WHO issued a separate alert on five batches of contaminated cough syrup ingredients found in Pakistan, that appeared to be falsely labeled as Dow Chemical products. It was the first alert the WHO has sent on elements of a drug rather than the finished products. 

“It was critical for WHO to also alert manufacturers that may have been procuring this material to exercise more caution,” said the U.N health agency spokesperson in an email.