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Concerns the FDA has flagged for this category generally - not specific to VivioMD - include: Dosing errors and confusion between milliliters, milligrams, and units in compounded injectable semaglutide Products sold as "semaglutide" that may actually contain salt forms such as semaglutide sodium or semaglutide acetate, which differ from the FDA-approved active ingredient and haven't been evaluated for safety or effectiveness Improper storage and shipping conditions for compounded injectables Fraudulent labels and doses beyond approved-label schedules Underreported adverse events across the compounded-GLP-1 category The FDA recommends that compounded drugs be used only for patients whose medical needs cannot be met by an FDA-approved drug - not as a default lower-cost substitute

The FDA warns that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs for weight loss, potentially exposing consumers to counterfeit or unsafe products

Presented for research literature review only Mondillo S et al

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