WHO to issue wider alert on cough syrup that has sickened children in Africa

The syrup has been pulled from shelves in several African countries.

The World Health Organization said in an email Friday that it is likely to issue a wider warning about contaminated Johnson and Johnson-made children’s cough syrup found in Nigeria last week.

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A batch of Benylin children’s cough syrup was recalled last week after it was found to have high levels of diethylene glycol, according to Reuters.

Diethylene glycol, along with another contaminate, ethylene glycol, has been linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia and Uzbekistan since 2022, according to Reuters.

The syrup “contains an unacceptable high level of diethylene glycol and was found to cause acute oral toxicity in laboratory animals,” the Food and Drugs Administration and Control in Nigeria said in a public alert on Wednesday.

According to the WHO, it was the first alert the organization has sent on excipients - elements of a medicine other than the active pharmaceutical ingredient - rather than finished products.

The lot that was recalled was made in South Africa in 2021, according to Bloomberg, and is set to expire this month, the regulator said.

This is the ninth known example of industrial solvents turning up in children’s syrup medication in recent years, according to Bloomberg.

The South African Health Products Regulatory Authority (SAHPRA) recalled the two batches of Benylin pediatric cough syrup on April 10 after it received the report that in regular testing the syrup was found to have dangerously high levels of diethylene glycol.

“SAHPRA immediately contacted the South African manufacturer, Kenvue, formerly Johnson and Johnson, for a response. Following engagements with the manufacturer and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation is ongoing,” according to SAHPRA.

These affected batches have been distributed to several countries including South Africa – where it was made -- Eswatini, Rwanda, Kenya, Tanzania, Zimbabwe and Nigeria. There are no known batches of the affected cough syrup outside of Africa.

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