fda compounding semaglutide warning letters november 2025 The has received reports of adverse events after patients used compounded versions of semaglutide. Some compounders may also be using unapproved salt forms. Patients should avoid compounded when an FDA-approved How GLP-1s Broke Healthcare Distribution

Semaglutide has already attracted interest in the context of hormonal conditions like PCOS, where the relationship between body weight, insulin sensitivity, and reproductive hormones is well established

However, data emerged showing adverse CV outcomes with some recently approved treatments for T2D, leading the US Food and Drug Administration (FDA) to issue a Guidance for Industry in 2008 that required all new glucose-lowering agents to demonstrate that no additional CV risk occurred as a result of taking a glucose-lowering agent(s) (FDA Background Document, 2018

Ozempic: A Proven Treatment for Weight Loss and Diabetes Ozempic, a medication containing semaglutide, was originally developed to treat type 2 diabetes

Research indicates that compounded versions may achieve weight loss results, albeit potentially less consistent than their FDA-approved counterparts

Nelson K et al

For these people, the access equation is completely different