The US Food and Drug Administration issued a warning about compounded versions of the drug semaglutide, which is approved for treatment of diabetes and excess weight.
Compounding “is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” the FDA says. “Compounding includes the combining of two or more drugs.” Semaglutide, a type of drug called a GLP-1 agonist, is FDA-approved as Ozempic and Rybelsus to treat type 2 diabetes and as Wegovy to treat overweight and obesity. Ozempic and Wegovy have been on the FDA’s Drug Shortages list since last year.
” Some compounders may also be using salt forms of the medication, such as semaglutide sodium and semaglutide acetate, which have different active ingredients from those in the approved drugs. “The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements. … Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.
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