Alert Issued on Contaminated Syrup ‘Naturcold’ by World Health Organization
The World Health Organization (WHO) has recently issued an alert regarding a contaminated syrup called ‘Naturcold’. The alert focuses on a substandard batch of the product that was identified in Cameroon and first reported to the WHO on March 13, 2023. The UN health agency has stated that it took necessary precautions to verify the information and will provide updates as more details become available.
The syrup, declared to contain paracetamol, phenylephrine hydrochloride, and chlorpheniramine maleate, is commonly used to relieve symptoms associated with the common cold, flu, and allergic rhinitis.
Samples of the Naturcold syrup from Cameroon were obtained by the WHO on June 27, 2023, and were analyzed in a pre-qualified laboratory contracted with the agency. The analysis revealed that the product contained unacceptable amounts of diethylene glycol, a toxic contaminant. The presence of diethylene glycol was detected in Naturcold samples, reaching levels as high as 28.6%, while the acceptable limit is not higher than 0.10%.
Diethylene glycol and ethylene glycol are highly toxic to humans when consumed and can be fatal. The WHO warns that the use of these contaminated products, especially in children, can result in serious injury or even death. Toxic effects may include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status, and acute kidney injury.
As a result, the WHO advises anyone who may have the Naturcold syrup at home to refrain from using it.
Adding to the concern is the mystery surrounding the product’s origin. The declared manufacturer, Fraken International (England), listed on the packaging, reportedly does not exist according to the UK regulatory body, MHRA. Investigations are currently underway to determine the actual source of the product, and the declared producer has not provided any guarantees regarding its safety and quality to the WHO.
Furthermore, the WHO highlights the possibility that the contaminated syrup may have marketing authorizations in other countries or regions worldwide. It might have also been distributed through informal markets to neighboring countries of Cameroon. This alert follows four previous warnings by the WHO regarding contaminated liquid dosage drugs, two in 2022 and two in 2023. The organization emphasizes the need for greater surveillance and diligence within supply chains to tackle these issues and calls for increased monitoring of the informal and unregulated market.
Manufacturers of liquid formulations, particularly syrups containing excipients such as propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol, are strongly advised to test for the presence of contaminants like ethylene glycol and diethylene glycol before using them in medicines. Healthcare professionals are also urged to report any suspected adverse events related to the use of contaminated medicines to the national regulatory authorities and the National Pharmacovigilance Center.
The WHO’s alert serves as a crucial reminder for consumers, healthcare professionals, and regulatory bodies to remain vigilant and prioritize the safety and quality of medicinal products.