US FDA joins world regulators probing tainted abroad cough syrup

Published: February 06, 2023

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The US Food and Drug Administration stated it’s working with the World Health Organisation and international regulatory authorities to assist an investigation into the supply of contaminated cough syrups which have killed greater than 300 youngsters in Africa and Asia.

In an announcement, the FDA stated it had no indication that contaminated syrups had entered the US drug provide chain, however it’s “investigating the potential impact and scope of this hazard on FDA-regulated products”.

The company really helpful customers solely take medicines that have been made to be bought within the United States, particularly for youngsters.

“The FDA is taking the international tragedy seriously and is making every effort to prevent contaminated product from entering the US market and to identify dangerous products that may have been brought into the US,” the assertion stated. The inquiry additionally entails the US Centers for Disease Control and Prevention.

Earlier this week, the WHO stated it had expanded its investigation into contaminated cough syrups linked to deaths from acute kidney harm in Gambia, Indonesia and Uzbekistan to 4 further international locations, and referred to as on governments extra broadly to make sure that medicines on the market are accepted by competent authorities.

Samples of the syrups, produced by six completely different drugmakers in India and Indonesia, have been discovered to be contaminated with a identified toxin, both diethylene glycol or ethylene glycol. The firms have both denied that their merchandise have been contaminated or declined to remark whereas investigations are ongoing.

Reuters reported that the WHO can also be investigating whether or not there may be any connection between the producers. In explicit, the company seeks extra details about the precise uncooked supplies used and whether or not they have been obtained from any of the identical suppliers.

The FDA stated it was devoting elevated oversight to syrups and different liquid medicines and has notified producers and international regulators to remind them that merchandise exported to the United States should meet good manufacturing apply necessities.

“Drug standards and regulations vary from country to country, and the FDA only has direct regulatory authority over the manufacture and distribution of products intended for use … and sold inside the US,” the assertion stated.

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