Manila: The Food and Drug Administration (FDA) on Monday (October 24) reaffirmed a previous alert from the World Health Organisation (WHO) concerning four "substandard" children's cough syrups.
According to the WHO, the cough syrups made by Maiden Pharmaceutical Ltd. and sold under the brand Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup are not safe to consume since they contain "toxic chemicals."
Maiden Pharmaceutical Ltd. is based in India.
The warning was made after 66 children died in the Gambia in West Africa last September.
'Hazardous to humans'
The FDA stated in its advisory that the four products include ethylene glycol and diethylene glycol, which are hazardous to humans and are regarded as pollutants, local media reported.
Consumption “may cause severe kidney injury which may result in mortality, abdominal discomfort, vomiting, diarrhoea, difficulty to pass urine, headache, changed mental state,” it stated.
FDA director general Dr. Manuel Zacate stated that because the drug's maker “has not offered guarantees to WHO on the safety and quality of these items, all batches of these medicines should be considered unsafe until they can be examined by the appropriate National Regulatory Authorities.”
Identify, remove from circulation
The drugs are not FDA-registered, and according to Zacate, “it is crucial to identify and remove these goods from circulation to prevent harm to patients."
He called on local government units and law enforcement agencies to see to it that the paediatric drug products are not sold or administered to patients in their localities or areas of jurisdiction.
He urged local government entities and law enforcement organisations to take steps to ensure that paediatric medication items are not offered for sale or given to patients within their jurisdictions.