Jan 25 (Reuters) – The U.S. Food and Drug Administration said on Wednesday it was working with the World Health Organization and foreign regulatory authorities to support an investigation into the source of tainted cough syrups that have killed more than 300 children in Africa and Asia.
In a statement, the FDA said it had no indication that tainted syrups had entered the U.S. drug supply chain, but is “investigating the potential impact and scope of this hazard on FDA-regulated products”. The agency advised consumers to only take drugs designed to be sold in the United States, especially for children.
“The FDA takes the international tragedy seriously and is working hard to prevent contaminated products from entering the U.S. market and to identify unsafe products that may have entered the United States,” the statement said. The investigation also involves the US Centers for Disease Control and Prevention.
Earlier this week, the WHO said it had expanded its investigation into tainted cough syrups linked to deaths from acute kidney injury in The Gambia, Indonesia and Uzbekistan to four more countries, and called governments more broadly to ensure that drugs for sale are approved by competent authorities. authorities.
Samples of syrups, produced by six different drugmakers in India and Indonesia, were found to be contaminated with a known toxin, either diethylene glycol or ethylene glycol. The companies have either denied their products were contaminated or declined to comment while investigations are ongoing.
Reuters reported that the WHO is also investigating whether there is a link between the manufacturers. In particular, the agency is looking for more information on the specific raw materials used and whether they were obtained from one of the same suppliers.
The FDA said it is devoting increased scrutiny to syrups and other liquid medications and has notified foreign manufacturers and regulators to remind them that products exported to the United States must meet good manufacturing practice requirements.
“Drug standards and regulations vary from country to country, and the FDA has only direct regulatory authority over the manufacture and distribution of products intended for use … and sold in the United States. “, reads the press release.
Reporting by Patrick Wingrove in New York; Editing by Michele Gershberg, Chris Reese and David Gregorio
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