More Than 1 Million Americans Are Taking Ozempic and Other GLP-1s Without an Approved Reason. Is That Actually a Problem?

Key Points:

• Recent research reveals that over 1.1 million Americans have been prescribed GLP-1 medications like semaglutide and tirzepatide without FDA-approved indications such as obesity or type 2 diabetes since 2021.
• The study analyzed data from over 300 million patient records and found a 13.6-fold increase in off-label GLP-1 prescriptions between 2021 and 2025, rising from 0.11% to 1.5% among adults without recorded indications.
• Some off-label use may be justified due to underrecording of conditions or emerging treatments, but concerns remain as about one-third of off-label users had normal BMI and a higher likelihood of eating disorders, raising questions about misuse.
• Off-label GLP-1 prescriptions were more common among women, white individuals, those with private insurance, and residents of less socially vulnerable areas, suggesting disparities in access and use.
• While GLP-1 drugs have significantly improved obesity and diabetes treatment and could save tens of thousands of lives if expanded, the risks and benefits for off-label users remain uncertain and warrant cautious consideration.