Since 2021, over 1.1 million Americans have received GLP-1 prescriptions—including Ozempic and Wegovy—for uses not officially approved by the FDA. New research from scientists at New York University suggests that while these prescriptions are still a minority of total use, their frequency is accelerating rapidly.

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A 13.6-fold increase in off-label GLP-1 use since 2021

The study, which utilized the COSMOS dataset containing over 300 million patient records from Epic Systems software, highlights a dramatic shift in prescribing habits. According to the researchers, the rate of GLP-1 prescriptions among adults without an FDA-approved indication—such as type 2 diabetes or obesity—rose from just 0.11% in 2021 to 1.5% in 2025. This represents a 13.6-fold relative increase in a very short window.

The researchers focused their analysis on three primary medications: liraglutide, semaglutide, and tirzepatide. While liraglutide is an older option, tirzepatide has gained massive popularity for its ability to combine GLP-1 with the hunger-regulating hormone GIP. Despite the surge in off-label use, the study notes that the clinical benefits remain significant; a 2024 study estimated that expanding access to all eligible Americans could save roughly 40,000 lives annually.

Privileged access for white and privately insured patients

The data suggests that the expansion of these drugs into off-label territory is not occurring uniformly across the population. The report indicates that off-label prescriptions are more common among women, white people, and individuals with private insurance. Furthermore, these users tend to come from less socially vulnerable areas, suggesting that the trend of using GLP-1s for non-approved reasons may be accruing disproportionately to more advantaged socioeconomic groups.

This demographic trend creates a stark contrast to the potential for widespread public health benefits. While the drugs have revolutionized the treatment of obesity and type 2 diabetes, the current off-label trajectory appears to be driven by those with the most robust healthcare resources rather than those with the highest clinical need.

The 6x higher risk of eating disorder history in normal-BMI users

One of the most striking findings involves the physical profile of off-label users . About one-third of those receiving off-label GLP-1s had a normal body mass index (BMI). Within this specific subgroup, researchers found that individuals were six times more likely to have a history of eating disorders compared to non-GLP-1 users.

While GLP-1 medications are currently being explored in clinical trials as potential treatments for substance use disorders and certain eating disorders, the current off-label surge raises concerns about the safety of these medications for individuals who do not meet the clinical criteria for obesity. The researchers noted that they could not reliably distinguish between different types of eating disorders, leaving a significant gap in understanding the long-term psychological implications of this trend.

The unexamined variable of compounded GLP-1 drugs

Despite the breadth of the COSMOS dataset, several critical questions remain regarding the full scope of the GLP-1 market. The study did not examine the use of compounded GLP-1 drugs, which are custom-made vesions that may carry different safety profiles than brand-name medications like Ozempic or Wegovy. As these custom alternatives become more common, their impact on off-label trends reains a major unknown.

Furthermore, the researchers cautioned that the study's findings may be limited by the accuacy of medical records. Specifically:

  • BMI and weight-related conditions may be underrecorded in the COSMOS dataset.
  • Some individuals may have qualified for a GLP-1 before entering the database.
  • The study could not account for users who lost significant weight and no longer met the criteria for obesity in their records.