Metro Manila (CNN Philippines, October 25) — The Food and Drug Administration (FDA) has warned the public against consuming four India-made pediatric drug products containing harmful substances which it said may lead to death.
In its advisory on Oct. 21, the FDA identified the “substandard” products as Promethazine Oral Solution BP, Kofexmalin Baby Cough Syrup, MaKOFF Baby Cough Syrup, and MaGrip n Cold Syrup which were all manufactured by the New Delhi-based firm Maiden Pharmaceuticals Ltd.
The agency specified a lot number in each of the four medicines, but said “all batches of these products should be considered unsafe” until otherwise proven by regulatory authorities.
The World Health Organization (WHO) likewise earlier issued an advisory after the contaminated products were detected in the African region in September.
The FDA said the products contain diethylene glycol and ethylene glycol which are toxic to humans when consumed. It explained these contaminants may cause abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may result in death.
Its advisory further stated that the medicines are not registered with the agency and that the manufacturer has not yet guaranteed the safety and quality of its products to WHO.
“It is important to detect and remove these products from circulation to prevent harm to patients,” the FDA said.
The regulatory body also urged local government units to take action on the matter.
Indonesia has suspended the sale of all syrup and liquid medicines following the deaths of nearly 100 children and an unexplained spike in cases of acute kidney injuries, CNN reported last week.
India’s Health Ministry said the ban will remain until authorities complete the probe into unregistered medical syrups suspected of containing toxic ingredients.
