FDA Joins Other Agencies To Investigate Cough Syrup

FDA Investigating International Cough Syrup Concerns

(VitalNews.org) – In October 2022, the World Health Organization (WHO) reported about a problem with four products in Gambia: Kofexmalin Baby Cough Syrup, Magrip N Cold Syrup, Promethazine Oral Solution, and Makoff Baby Cough Syrup. According to WHO, Maiden Pharmaceuticals Limited manufactured those cough syrups, which reportedly contained harmful and potentially lethal contaminants. The agency suspects the medications caused 66 pediatric deaths and some kidney injuries.

On January 26, CBS News reported that the Food and Drug Administration (FDA) was joining the WHO, the CDC, and other organizations to investigate the incidents. The FDA did not provide any evidence the products had entered the US market. Previous reports from the health organization stated the medicines contained diethylene glycol and ethylene glycol — toxins that can lead to kidney injuries and death. CBS News reported officials estimated the possible child death toll at over 300 in Africa and Asia.

In November 2022, the Office of Global Policy and Strategy (OGPS) with the FDA released a statement about the incident. The group vowed to get to the bottom of the issue while reminding drug manufacturers to stick to the Testing of Glycerin for Diethylene Glycol guidelines to ensure the safety of products before distribution. The OGPS also pointed to the CDC for information about the effects of ethylene glycol, including treatments and antidotes.

Given the seriousness of the problem, the message indicated the FDA was giving special attention to syrups or other products made with sorbitol, glycerin, or propylene glycol. The FDA recommended consumers in the United States stick to using only medications made for the US market, as the administration has strict standards for safety reasons.

The federal agency said the “safety, quality, and effectiveness” of drugs remains its top priority for America. It issued a statement saying, “The FDA is taking the international tragedy seriously” as it continues efforts to protect US citizens, including involving the Centers for Disease Control (CDC) in the inquiries, according to Reuters.

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