FDA cautions public, providers to avoid use of compounded salt forms of semaglutide
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The FDA is advising people using semaglutide to avoid some compounded formulations due to the use of ingredients that may cause adverse events, according to a safety notice.
As of May, semaglutide (Ozempic/Wegovy, Novo Nordisk) appears on the FDA’s drug shortages list. According to the notice, compounded versions of drugs on the shortage list can be prepared if they meet certain requirements in the Federal Food, Drug and Cosmetic Act.
However, the FDA stated it has concerns with ingredients used in compounded semaglutide that may violate Federal Food, Drug and Cosmetic Act requirements. According to the notice, the FDA has received reports that some compounded semaglutide formulations may be using salt forms of the agent, including semaglutide sodium and semaglutide acetate. These forms are different from the formulations used in the FDA-approved drugs, and the agency said it is not aware of any basis for compounding using salt forms that would meet Federal Food, Drug and Cosmetic Act requirements. The FDA stated it has received reports of adverse events from patients using compounded semaglutide.
The FDA advised providers and the public to avoid the use of a compounded drug if the approved drug is available. The agency also noted that some products sold as semaglutide may not contain the same ingredients as the FDA-approved products and that salt formulations of semaglutide have not been evaluated for safety or efficacy. Users are advised to obtain semaglutide only with a prescription from a licensed health care provider and from state-licensed pharmacies or outsourcing facilities registered with the FDA.
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