FDA Warns Against Substandard Indian Cough Pediatric Medicines

The Food and Drug Administration (FDA) is against the consumption of four pediatric medicines from India containing harmful matter that may cause death.

This comes as the FDA published an advisory on October 21 in which they identified four substandard products produced by a single pharmaceutical firm.

The said cough and cold medicines, Promethazine Oral Solution BP, Kofexmalin Baby Cough Syrup, MaKOFF Baby Cough Syrup, and MaGrip n Cold Syrup, are manufactured by New Delhi-based firm Maiden Pharmaceuticals Ltd.

The FDA added that while there is a specified lot number for the four medicines, all batches of the medicines are to be “considered unsafe.”

The medicines contain diethylene glycol and ethylene glycol, substances that are harmful to humans when consumed.

The substances may cause several complications, such as abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death, according to the FDA advisory.

As of writing, Maiden Pharmaceuticals Ltd. has not provided safety and quality guarantees of the medicines to WHO.

Moreover, the medicines are yet to be registered with the FDA.

“It is important to detect and remove these products from circulation to prevent harm to patients,” the FDA said.

This is the latest development of the initial discovery of the World Health Organization (WHO) wherein the UN agency issued an alert on October 5 as the four cough and cold syrups from Maiden Pharmaceuticals Ltd may be linked with the death of 66 children in The Gambia.

The FDA is also urging local government units and law enforcement agencies to act against the sale and administration of contaminated products in their localities and areas of jurisdictions. (GFB)