More than 1.1 million U.S. adults were prescribed GLP-1 medications despite having no FDA-approved indication documented in their electronic health records, a new study found, raising questions about rapidly expanding off-label use among people without diabetes or qualifying obesity.
By yourNEWS Media Newsroom.
More than 1.1 million American adults received prescriptions for GLP-1 medications despite having no approved medical indication recorded in their electronic health records, according to a new study examining the rapid expansion of drugs such as semaglutide, tirzepatide and liraglutide.
Researchers at New York University analyzed Cosmos electronic health records covering January 2021 through December 2025 and identified 92,415,648 adults whose charts showed neither Type 2 diabetes nor obesity accompanied by a qualifying weight-related condition.
Among that population, 1,133,953 people — about 1.2% — were prescribed a GLP-1 medication.
Use within that group accelerated sharply over the five-year period, climbing from 0.1% in 2021 to 1.5% in 2025, representing a 15-fold increase.
The findings, published online in the journal Obesity, do not establish that all of those prescriptions were medically unnecessary.
Researchers identified patients whose available records did not show an FDA-approved indication for treatment. That is different from determining that physicians had no clinical reason for prescribing the medications. Diagnoses could have been missing from the database or documented elsewhere, and doctors are legally permitted to prescribe FDA-approved drugs for off-label uses.
Still, the scale and speed of the increase have attracted attention because GLP-1 medications have primarily been studied in patients with established metabolic or weight-related conditions.
Ozempic, for example, is approved for adults with Type 2 diabetes and has additional cardiovascular and kidney-related indications in certain patients. Wegovy is approved for chronic weight management in people who meet specified obesity or overweight criteria.
The New York Times reported that researchers believe some patients outside those groups may be seeking the drugs to lose relatively small amounts of weight or because of growing interest in possible benefits beyond their currently established indications.
“You see it all over the place. You have people describing publicly their experience with these medications, some good, some bad,” said Dr. Babak Orandi, an obesity medicine specialist and transplant surgeon at N.Y.U. Langone Health and the study’s lead author.
The positive anecdotes, he said, “may open up people’s curiosity to say, ‘Hey, maybe that could work for me.’”
Interest has expanded beyond weight loss as researchers investigate potential effects involving cardiovascular disease, neurological conditions and biological aging. Some preliminary research has examined whether GLP-1 medications might influence measures associated with biological aging, although such findings do not establish the drugs as approved longevity treatments.
Orandi said some patients have also expressed interest in using GLP-1 drugs in hopes of improving conditions such as high cholesterol or hypertension.
One of the study’s more notable findings was that more than one-third of patients receiving GLP-1 medications without a documented approved indication had a normal body mass.
Researchers also identified patients with eating disorders among those receiving the drugs off label, raising additional concerns because GLP-1 medications suppress appetite and can lead to substantial weight loss.
The authors said the study could actually underestimate the number of people taking the medications outside established indications.
Its database did not capture all people obtaining GLP-1 drugs through direct-to-consumer telehealth companies or those using compounded versions of semaglutide or tirzepatide.
The dramatic increase in demand has transformed the medications from treatments primarily associated with diabetes into some of the most widely discussed drugs in the country.
Their effectiveness for appropriate patients is well established. GLP-1 medications can reduce appetite, improve blood sugar regulation and produce significant weight loss in people for whom treatment is indicated.
But researchers have considerably less information about their long-term effects in people who have normal body weight, do not have diabetes and otherwise fall outside the populations enrolled in major clinical trials.
That evidence gap is particularly important because losing weight is not the only physiological effect of treatment.
Some weight lost during GLP-1 therapy can come from lean tissue, including muscle. For people who do not have excess body weight to lose, researchers have raised questions about whether appetite suppression could contribute to inadequate calorie or nutrient intake.
Malnutrition and excessive loss of muscle mass are among the potential concerns identified by specialists when the medications are used in populations that have not been extensively studied.
Dr. Andrew Kraftson, an obesity specialist at the University of Michigan, said clinicians should consider more than whether a patient simply wants the medication.
Some primary care physicians facing patient requests may conclude, “Well what can it hurt.”
Kraftson cautioned that physicians still need to assess whether expected benefits justify possible risks for the individual patient.
The medications also commonly cause gastrointestinal side effects, including nausea, vomiting, diarrhea and constipation, and patients generally require medical supervision while taking them.
For people with diabetes, obesity or another established indication, those risks can be weighed against benefits demonstrated in clinical research.
That calculation becomes less certain when medications are prescribed to people outside the populations for which extensive clinical evidence exists.
The new research therefore does not conclude that 1.1 million Americans received GLP-1 drugs “for no reason.” Instead, it documents more than 1.1 million adults whose available electronic records contained no approved indication explaining their prescriptions.
That distinction is important because off-label prescribing is common and legal in American medicine, and a physician may have an individualized clinical rationale that is not reflected in a research database.
The concern raised by the authors is the speed at which use is expanding among people whose potential benefits and risks remain comparatively understudied.
“We don’t know how this will play out,” said Dr. Nils Krüger, a researcher at Harvard Medical School. “It’s like this big Ozempic experiment.”
Original article
Comments