At least four African nations withdraw child cough syrup over toxicity fears
At least four African countries have now withdrawn a batch of the well-known Benylin children’s cough syrup, after a medicines watchdog found high levels of a toxic solvent linked to scores of poisoning deaths.
Rwanda at the weekend joined Nigeria, Kenya and South Africa in recalling a batch of the syrup made by drugs giant Johnson and Johnson, which had been exported to a total of six African countries.
Laboratory tests by Nigeria’s health regulator last week reported high levels of diethylene glycol, which has been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since 2022. Those deaths were traced back to different cough syrups manufactured in India and Indonesia.
The recalled Benylin batch was made in May 2021. J&J last year spun off its consumer health division, including the Cape Town factory that produces Benylin, to a separate company known as Kenvue Inc.
South Africa said it was also recalling a second batch of the same clear, bright red, raspberry flavoured medicine.
There have been no deaths or injuries reported linked to the Benylin batch.
The recalled batch was made in South Africa and also distributed in Eswatini, Rwanda, Kenya, Tanzania and Nigeria.
J&J referred inquiries about Benylin to Kenvue.
Kenvue, based in Skillman, New Jersey, said: “We take this matter very seriously and are acting with urgency to conduct a thorough safety and quality assessment.”
A spokeswoman told the Telegraph the particular product, Benylin Paediatric Syrup, and its formulation were not sold in the UK.
The company said it was working with the Nigerian watchdog “to understand more as we conduct our own assessment, including verifying the authenticity of the sampled product, testing methodology used and results reported by the agency”.
“We are working with health authorities to determine the appropriate course of action,” a statement added.
The company told the Telegraph that both recalled batches – 329304 and 329303 – expire in April 2024.
There had been no reported health problems for either batch, according to its global safety database.
South Africa said it had recalled batches numbered 329304 and 329303 and urged the public not to panic, but said the medicine was being recalled from hospitals, clinics, shops, medical staff and patients.
Diethylene glycol (DEG) is toxic to humans and can prove fatal. Symptoms include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.
The global cough syrup market has seen a spate of poisonings and the new batch of Benylin is thought to be at least the ninth known example of industrial solvents turning up in children’s syrup medication in recent years.
Such medicines are typically contaminated when propylene glycol, a harmless compound used to dissolve active ingredients, is replaced or mixed with either of two cheaper, toxic solvents, diethylene glycol or ethylene glycol.
The toxic solvents have similiar chemical properties and can be introduced accidentally in the supply chain, or even by deliberate adulteration because they are cheaper than propylene glycol.
During the Covid pandemic, propylene glycol also became scarce and more expensive due to supply-chain disruptions.
Contaminated syrups have been linked tf the deaths of 350 small children in Indonesia, Uzbekistan, Gambia and Cameroon in the past two years.
In each case, there was confirmed or suspected contamination of the medicines with solvents called diethylene glycol (DEG) or ethylene glycol (EG).
The tainted medicines in Gambia and Uzbekistan were linked to Indian manufacturers and the medicines in Indonesia were manufactured domestically.
Protect yourself and your family by learning more about Global Health Security
