2023-07-19 18:49:01
A new alert on a contaminated syrup has been launched by the World Health Organization (WHO). At the heart of the communication from the UN health agency is a product called ‘Naturcold’. The alert refers to a substandard, sub-standard batch identified in Cameroon and first reported to WHO on March 13, 2023. The agency said in a statement that it had taken all reasonable precautions to verify the information. . The alert may be updated as more information becomes available. The declared active ingredients for this syrup are paracetamol, phenylephrine hydrochloride and chlorpheniramine maleate. The combination of these three ingredients is used to relieve symptoms associated with the common cold, flu and allergic rhinitis.
Samples of the syrup from Cameroon were made available to WHO on 27 June 2023 and analyzed in a pre-qualified laboratory contracted with the agency. The analysis, explains the WHO, “found that the product contained unacceptable amounts of diethylene glycol as a contaminant”. Its presence was detected in Naturcold samples “up to 28.6%. The acceptable limit for diethylene glycol is not higher than 0.10%”, informs the institution. Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. The products involved in the warning “are not safe – urges the WHO – and their use, especially in children, can cause serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to urinate, head, altered mental status and acute kidney injury which can lead to death”. The UN agency therefore advises anyone who may have the product at home not to use it.
But there is also a mystery about the origin of the product. “The claimed manufacturer is listed on the product packaging as Fraken International (England) – reports WHO – The UK regulatory body, the MHRA, has confirmed” however “that no such company exists in the UK. They are investigations are still ongoing to determine the origin of the product. Therefore, the declared producer has not provided guarantees to WHO on the safety and quality of these products”.
Lastly, the World Health Organization points out that the product referred to in the notice could also have marketing authorizations in other countries or regions of the world. It may also have been distributed through informal markets to countries neighboring Cameroon. In recent months, the WHO had published 4 warnings on other contaminated liquid dose medicines, two in 2022 and two in 2023. And today it calls for “greater surveillance and diligence within the supply chains of countries and regions that may be affected from these products, as well as increased surveillance of the informal-unregulated market”.
“Manufacturers of liquid formulations, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol and/or glycerin/glycerol, are advised to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines” , adds the agency. While healthcare professionals “must report any suspected cases of adverse events related to the use of contaminated medicines to the national regulatory authorities-National Pharmacovigilance Center”.
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