THE Food and Drug Administration (FDA) yesterday warned the public against four pediatric drug products that are potentially deadly to consumers.
It said the warning was issued based on the medical product alert of the World Health Organization (WHO) on the four substandard (contaminated) pediatric drug products which were detected in the African region last month.
In Advisory No.2022-1763, the FDA said the manufacturer, Maiden Pharmaceuticals Ltd., has yet to provide guarantees to the WHO on the safety and quality of its products which are not registered with the Philippine government.
The FDA said the products have the contaminants diethylene glycol and ethylene glycol which are “toxic to humans when consumed.”
It said ingestion may result in abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury.
The FDA identified the four products as Promethazine Oral Solution BP; Pheniramine Maleate, Ammonium Chloride, Menthol (Kofexmalin Baby Cough Syrup); Chlorphenamine Maleate, Phenylephrine HBr, Dextromethorphan (MaKOFF Baby Cough Syrup); and Paracetamol Phenylephrine HCl, Chlorphenamine Maleate (MaGrip n Cold Syrup).
