MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against the purchase and use of four contaminated pediatric drug products.
In an advisory yesterday, the FDA said the World Health Organization recently issued a Medical Product Alert on four substandard cough medicines for children, which were detected in the African region in September.
These are 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). All products are manufactured by Maiden Pharmaceuticals Ltd.
FDA director general Samuel Zacate advised the public to be aware of these substandard drug products since the contaminants, diethylene glycol and ethylene glycol, are toxic to humans when consumed.
“It may cause abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death,” Zacate said.