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FDA Issues Safety Alert for Compounded Semaglutide Medications

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eMediNexus    03 June 2023

The FDA advises consumers not to use compounded medications as an alternative to known diabetic and weight reduction medications Ozempic, Rybelsus, and Wegovy.

 

Although compounded medications are not FDA-approved, they can be manufactured when there is a recognized drug shortage. The FDA has listed Ozempic and Wegovy as short of supply, but the federal body issued a warning on Tuesday related to "adverse events" after taking compounded versions of the medications by people. (The FDA denied mentioning the specifics of those incidents or the location where the compounded medications were made.)

 

Officials at the agency are worried that the compounded versions may contain components similar to the active ingredient in brand-name pharmaceuticals, Semaglutide. Still, they are distinct since they are in salt form.

 

In a statement to the National Association of Boards of Pharmacy, the agency stated that salt forms dont meet the requirements for compounding during a shortage and expressed "concerns with the use of the salt forms in compounded products."

 

The Board of Directors of the Alliance for Pharmacy Compounding stated that some compounders defenses of semaglutide sodiums appropriateness are "worthy of discussion," but the board did not support those defenses. The FDA suggests using BeSafeRx on the FDA website to verify an online pharmacys qualifications before using it.

 

(Source: https://www.medscape.com/viewarticle/992632)

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