fda warning compounding semaglutide october 2025 Warns on Certain Forms of Compounded Societies take stand against off-brand

Cavero-Redondo I, Martinez-Vizcaino V, Fernandez-Rodriguez R, Saz-Lara A, Pascual-Morena C, lvarez-Bueno C

Small changes can make a difference

Before determining that a shortage is resolved, FDA considers a variety of factors, including the company's ability to meet current and historical demand, the amount in a manufacturers stock, affected market share, ability of alternate manufacturers to cover the demand, and confirmed market stabilization

this warrants ongoing monitoring No unexpected serious cardiovascular signals were identified during the limited Phase 2 follow-up period, though the trials were neither designed nor powered to assess cardiovascular outcomes, and longer-term data are not yet available At present, the overall safety profile appears broadly consistent with other GLP-1-based therapies, but definitive conclusions cannot be drawn until Phase 3 data and post-marketing surveillance are available

Any test with the NZ Drug Foundation is free and confidential

Suddenly, individuals without diabetes were seeking the medication as a weight loss aid, leading to a surge in off-label use