Two weeks ago, contaminated children’s cough syrup made by Johnson & Johnson (JNJ.N) was found in Nigeria, prompting the World Health Organization (WHO) to consider increasing its alarm on the product. The Nigerian regulatory agency ordered a recall of a group of Benylin pediatric syrup after tests showed high levels of Diethylene glycol, a harmful contaminant. Despite the deaths of more than 300 children in Cameroon, Gambia, Indonesia, and Uzbekistan since 2022 being linked to diethylene glycol and ethylene glycol, there is no proof connecting these tragedies to the recent product recalls.
Pending confirmation of specific details from all parties involved, the WHO is set to issue global alerts regarding medical products to alert national authorities. The batch of Benylin syrup being recalled was manufactured by Johnson & Johnson in South Africa in May 2021. The brand is currently owned by Kenvue (KVUE) after being spun off from J & J last year. When asked, Kenvue confirmed that they had tested the recalled batch and found no traces of diethylene or ethylene glycol.
Investigating is ongoing on the contamination of syrup in Nigeria.
Kenvue released a statement highlighting its commitment to working with health authorities and the WHO. The company is eager to partner with Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) to validate test results and guarantee the authenticity of their products. Following Nigeria’s recall, Kenya, Rwanda, Tanzania, Zimbabwe, and South Africa have all decided to take the product off market as well. The regulatory authority in South Africa has decided to recall another batch of the syrup due to safety concerns. Despite the potentially harmful effects of diethylene glycol, such as acute kidney failure if consumed, there have been no reported negative outcomes in this particular situation.
Also, the WHO is currently working in collaboration with both the manufacturer and South Africa’s regulatory authority to investigate the contamination of syrup in Nigeria. Kenvue has assured that they follow strict testing protocols for ingredients prior to manufacturing. In a separate incident, the WHO has issued a warning about contaminated cough syrup ingredients found in Pakistan, highlighting the need for manufacturers to exercise caution. The recent WHO alert was centred around propylene glycol, a substance that is not found in Benylin pediatric syrup.
Initial warnings have been issued about excipients.
In an investigation initiated by the WHO is looking into the potential of the syrup being fake, in addition to other factors. Just recently, the WHO issued a warning about contaminated cough syrup ingredients in Pakistan, which were incorrectly labelled as Dow Chemical products. WHO issued its initial warning about excipients, which are components of medication distinct from the main pharmaceutical ingredient, rather than the final products themselves. It was determined that the propylene glycol batches were tainted with ethylene glycol.
The World Health Organization warned that the presence of diethylene glycol and ethylene glycol in over-the-counter cough syrups is highly dangerous, as these toxic chemicals are typically used in industrial solvents and antifreeze. Even small doses of these contaminants can be lethal, making their presence in medicines unacceptable. In October and earlier January, the WHO issued urgent warnings regarding certain cough syrups manufactured by Maiden Pharmaceuticals and Marion Biotech in India, which have been associated with fatalities in Gambia and Uzbekistan. These alerts called for the immediate removal of these medicines from the market shelves.
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All stakeholders involved in the medical supply chain to work together and take prompt action, as they are not isolated occurrences, WHO stated. The organization also restated its plea for the removal of the mentioned products from circulation, and emphasized the importance of countries ensuring all medications for sale are approved by relevant authorities. It further stressed the importance of governments and regulators allocating resources for inspecting manufacturers, boosting market surveillance, and intervening when necessary. A spokesperson also stressed the need for the WHO to notify manufacturers who may have been acquiring this material to be more cautious.