FDA Warns on Unapproved, Compounded GLP-1 Drugs, Citing Dosing Errors and Fraud

The FDA is warning consumers about unapproved and compounded GLP-1 drugs, including semaglutide and tirzepatide, citing dosing errors, quality issues, and fraudulent products. The news could weigh on $HIMS, $NVO, and $LLY in the short term.
The agency said retatrutide and cagrilintide cannot legally be used in compounding and have not been found safe and effective for any condition.
As of May 31, the FDA had received 990 adverse-event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide.