FDA joins international investigation into contaminated cough syrups that have killed over 300 children
The Food and Drug Administration announced Wednesday that they are partnering with the World Health Organization and other international partners to investigate the source of contaminated cough syrups that have killed more than 300 children in Asia and Africa.
The international reports of contaminated products were announced by the WHO on Oct. 5, 2022. Over-the-counter cough syrups sold in several countries were found to be tainted with diethylene glycol and ethylene glycol, which are toxic to humans. According to Reuters, most of the children who died were under 5 years old and the cause of death was acute kidney injury.
There is no evidence at this time that the contaminated products have entered the U.S. supply, the FDA said. The stated manufacturer of those products, which include Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, was Maiden Pharmaceuticals Limited, a company in Haryana, India.
"Although the FDA currently has no indication that the products described in the 2022 and 2023 WHO alerts have entered the U.S. drug supply chain, the agency is investigating the potential impact and scope of this hazard on FDA-regulated products," the agency said in a statement provided to CBS News.
Strict safeguards have been implemented, the FDA said, and products made with "glycerin, propylene glycol, polyethylene glycol, maltitol solution, hydrogenated starch hydrolysate or sorbitol solution" are receiving "increased regulatory oversight." Manufacturers and overseas regulatory counterparts have been contacted by the FDA to make sure that their products are meeting current requirements and specifications.
"The FDA is taking the international tragedy seriously and is making every effort to prevent contaminated product from entering the U.S. market and to identify dangerous products that may have been brought into the U.S.," the agency said.
The agency recommends that consumers only take medications made to be sold in the U.S., especially when treating children.
"Our top priority is the safety, quality and effectiveness of the drug products available to the American public," the FDA said.