A new study reveals that over a million Americans are receiving GLP-1 medicines without approved indications, spotlighting rising off-label prescribing, potential disparities, and safety questions amid a rapidly expanding market.
A study published in the journal Obesity suggests that more than 1.1 million Americans have been prescribed GLP-1 medicines without a clear Food and Drug Administration-approved reason, underscoring how quickly drugs once used mainly for diabetes have moved into much broader use. The researchers, from New York University and other institutions, analysed medical records from a large electronic health record network and found that off-label prescribing of these medicines rose sharply between 2021 and 2025. According to the paper, the increase reflects both the huge demand for GLP-1s and the uncertainty that comes with using them outside their approved indications.
The analysis focused on adults who did not have a documented diagnosis that would normally justify a prescription for medicines such as semaglutide, sold as Ozempic and Wegovy, or tirzepatide, sold as Mounjaro and Zepbound. The team looked at people without recorded type 2 diabetes, obesity, or overweight with a weight-related complication such as high blood pressure, sleep apnoea or heart failure. Across roughly 90 million adults in that group, just over 1.1 million received a GLP-1 prescription during the period studied. The researchers said the rate rose from 0.11% in 2021 to 1.5% in 2025, a 13.6-fold increase.
That does not necessarily mean every prescription was inappropriate. The authors noted that medical records may not capture a patient’s full history, including past obesity, prior eligibility for treatment or changes in weight that occurred before a person entered the database. They also tried to reduce the risk of misclassification by excluding some patients whose body-mass index had not been recorded and by running a second analysis limited to people with no previous recorded history of obesity. Even so, the broad trend remained: off-label use increased over time, although the pool narrowed to about 350,000 people in that stricter analysis.
The findings raise questions because a sizeable share of off-label users appeared to fall outside the groups most commonly thought to benefit from these medicines. Roughly a third of the off-label GLP-1 users in the study had a normal body-mass index recorded, and they were six times more likely than non-users to have a history of eating disorders. The paper did not distinguish between different eating disorders, and the authors acknowledged that some GLP-1s are being explored as possible treatments for certain conditions, including binge-eating disorder and substance use disorders. But those uses remain experimental, and the overall risk-benefit balance in people without approved indications is still unclear.
The study also suggested that off-label access may be skewed towards more affluent patients. Women, white patients, people with private insurance and those from less socially vulnerable areas were more likely to receive these prescriptions, leading the authors to warn that expansion beyond approved uses may be accruing disproportionately to more advantaged groups. The analysis did not include compounded GLP-1 products, which are custom-made formulations that have also attracted scrutiny over safety and quality. Meanwhile, separate data cited in other research show how common GLP-1 use has become among people with diagnosed diabetes: in 2024, about 26.5% of adults with diabetes were using GLP-1 injectables, with use especially common among those aged 50 to 64 and among people with higher body mass index. Taken together, the evidence points to a fast-changing market in which legitimate need, off-label experimentation and unequal access are increasingly hard to separate.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
