The Food and Drugs Administration (FDA) on Monday echoed an earlier warning by the World Health Organization (WHO) against four “substandard” cough syrups for children.
The WHO tagged the cough syrups manufactured by India-based Maiden Pharmaceutical Ltd. under the brands Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup as unsafe for consumption because they contain “toxic ingredients.”
The warning was issued following the death of 66 children in the West African country of Gambia last September.
In its advisory, the FDA said the four brands contain diethylene glycol and ethylene glycol which are considered as contaminants and toxic to humans.
Consumption “may result in abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” it said.
The drugs’ manufacturer “has not provided guarantees to WHO on the safety and quality of these products. All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities,” Dr. Manuel Zacate, FDA director general, said.
The medicines are not registered with the FDA, and “it is important to detect and remove these products from circulation to prevent harm to patients,” Zacate said.
He called on local government units and law enforcement agencies to see to it that the pediatric drug products are not sold or administered to patients in their localities or areas of jurisdiction.
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