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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
Research priorities for heart failure with preserved ejection fraction: National heart, lung, and blood Institute working group summary
What are compounded semaglutide products potential risks and consequences compared to FDA-approved formulations, and how might healthcare professionals communicate these dangers to patients
On average, semaglutide led to a placebo-corrected weight loss of about 12%, while tirzepatide reached an impressive 18% reduction in body weight
And even in the (single) study which did suggest a link, the absolute risk still remained incredibly low only 1-2 cases per 10,000 people per year
doi: 10.1038/srep41063 154 GonzalezASalillasSVelazquez-CampoyAEspinosa AngaricaVFillatMFSanchoJet al
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