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Semaglutide Safety Study: UT San Antonio Research Shows Spike in US Poison Control Calls Post-FDA Approval

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A semaglutide injection pen is shown.
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Understanding the Surge in GLP-1 Receptor Agonist Exposures

The rapid rise in popularity of medications like semaglutide, known by brand names such as Ozempic for type 2 diabetes and Wegovy for chronic weight management, has brought renewed focus on their safety profile in real-world settings. A new study from researchers at The University of Texas at San Antonio examines national trends in calls to poison control centers, revealing a clear increase following regulatory approval for weight loss indications.

Glucagon-like peptide-1 receptor agonists, or GLP-1 RAs, work by mimicking a natural hormone that helps regulate blood sugar, slow gastric emptying, and promote feelings of fullness. These effects make them effective for managing diabetes and supporting weight reduction when combined with diet and exercise. However, as their use expanded, so did reports of unintentional exposures, primarily dosing errors leading to gastrointestinal discomfort.

The University of Texas at San Antonio Research Team and Methodology

Investigators from UT San Antonio's College of AI, Cyber and Computing and the South Texas Poison Center within the Long School of Medicine led the analysis. They reviewed data from the National Poison Data System spanning 2012 to 2023, comparing periods before and after the key regulatory milestone in mid-2021.

The team defined the pre-approval period as exposures before July 1, 2021, and the post-approval period afterward. This cutoff aligns with the FDA's June 2021 approval of semaglutide specifically for chronic weight management in adults with obesity or overweight with related conditions. They examined demographics, exposure circumstances, clinical effects, management sites, and outcomes using statistical methods including segmented Poisson regression to detect changes in reporting trends.

Key Findings on Call Volume Increases

Researchers identified a total of 10,033 GLP-1 RA exposures over the study period. Of these, 3,113 occurred before the approval cutoff and 6,920 afterward. Semaglutide accounted for 64.2 percent of post-approval cases, underscoring its dominant role in the observed trends.

Before mid-2021, national poison centers handled roughly 1,000 to 1,500 GLP-1 related cases annually. Volumes nearly doubled in the subsequent period, exceeding 8,000 calls by 2023. Segmented modeling confirmed a statistically significant inflection point, with semaglutide exposures rising an additional 9.9 percent per quarter after approval.

Demographic Shifts in Reported Exposures

The exposed population changed notably after approval. Cases involved younger individuals on average and a higher proportion of females. This shift reflects broader prescribing patterns as the medications gained traction for weight management beyond their original diabetes focus.

Most exposures were unintentional therapeutic errors rather than intentional misuse or abuse. Patients often took doses too close together, administered incorrect amounts due to pen device confusion, or encountered issues with compounded formulations that emerged during periods of high demand and supply shortages.

Insulin pen and its packaging are shown.

Photo by Haberdoedas on Unsplash

Clinical Outcomes and Healthcare Utilization

The majority of cases resulted in mild gastrointestinal symptoms such as nausea, vomiting, diarrhea, or abdominal pain. Severe outcomes remained uncommon. However, the proportion of exposures managed in or referred to a healthcare facility rose from 23.0 percent pre-approval to 33.5 percent post-approval.

This increase in healthcare facility involvement occurred despite the generally mild nature of effects, highlighting opportunities for better patient education on proper administration and expected side effects. The study notes that improved counseling could reduce preventable errors and unnecessary emergency evaluations.

Statistical Modeling and Trend Analysis

Beyond simple pre- and post-comparisons, the team applied segmented Poisson regression to account for underlying time trends and seasonal variations in poison center data. This approach confirmed that the acceleration in semaglutide-related calls represented a meaningful departure from prior patterns, while non-semaglutide GLP-1 RAs showed only modest growth.

Sensitivity analyses supported the robustness of these findings. The research provides a model for how poison center surveillance data can detect inflection points tied to new drug indications or expanded use.

Broader Context of GLP-1 Medication Adoption

Semaglutide received initial FDA approval for type 2 diabetes in 2017 under the Ozempic brand. The 2021 approval for weight management under Wegovy marked a pivotal expansion. Subsequent developments include higher-dose formulations and an oral tablet version approved later.

Demand surged due to demonstrated efficacy in clinical trials showing average weight reductions of around 15 percent or more when paired with lifestyle changes. Shortages prompted some patients to seek compounded versions, which carry additional risks related to variable dosing and lack of standardized safety review.

Implications for Toxicology and Public Health Research

This UT San Antonio-led work contributes to pharmacovigilance by characterizing acute exposure patterns in a national dataset. It underscores the value of interdisciplinary collaboration between computing, toxicology, and emergency medicine departments at universities.

Findings suggest that while GLP-1 RAs offer significant therapeutic benefits, their widespread adoption requires parallel efforts in patient education, clear dosing instructions, and accessible poison center guidance. The study recommends enhanced counseling to minimize therapeutic errors.

Medicine box and injection pens for medical use.

Photo by Haberdoedas on Unsplash

Future Outlook and Recommendations

As GLP-1 medications continue evolving with new formulations and indications, ongoing surveillance remains essential. Poison centers serve as a critical early warning system for emerging safety signals in real-world use.

Healthcare providers, pharmacists, and patients can benefit from resources on proper administration techniques. Individuals experiencing issues should contact poison control at 1-800-222-1222 for free, confidential advice available 24 hours a day.

Academic institutions like UT San Antonio play a vital role in training the next generation of researchers and clinicians equipped to analyze such trends and improve medication safety.

Stakeholder Perspectives on Medication Safety

Toxicologists emphasize that most calls involve manageable symptoms but highlight the need for proactive measures. Public health experts note the balance between innovation in obesity treatment and the responsibilities that come with rapid uptake of new therapies.

University-based poison centers contribute unique insights by combining clinical data with advanced analytical methods, fostering evidence-based approaches to emerging drug-related challenges.

Retrato de Dr. Oliver Fenton
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Frequently Asked Questions

💊What is semaglutide and how does it work?

Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that mimics a natural hormone to help control blood sugar, slow digestion, and reduce appetite. It is approved for type 2 diabetes under brands like Ozempic and for chronic weight management under Wegovy.

📅When was semaglutide approved for weight loss?

The FDA approved semaglutide (Wegovy) for chronic weight management in adults with obesity or overweight with weight-related conditions on June 4, 2021.

📈What did the UT San Antonio study find?

The study documented a significant increase in poison center calls for GLP-1 RAs after the 2021 approval, with semaglutide accounting for over 64 percent of post-approval cases and overall volumes more than doubling.

⚠️What were the most common issues reported?

Most exposures involved unintentional therapeutic errors such as incorrect dosing or timing, leading primarily to mild gastrointestinal symptoms like nausea and vomiting.

🏥Did healthcare facility referrals increase?

Yes, the proportion of cases managed in or referred to healthcare facilities rose from 23 percent before approval to 33.5 percent afterward.

👨‍🔬Who led the research at UT San Antonio?

The team included Jordan Miller and David Han from the College of AI, Cyber and Computing, along with Robert Miller and Shawn M. Varney from the South Texas Poison Center and Long School of Medicine.

✅How can patients avoid dosing errors?

Patients should follow prescribed instructions carefully, double-check doses with pharmacists, use only FDA-approved products from licensed sources, and contact poison control for any concerns.

☎️What role do poison centers play?

Poison centers provide 24/7 expert guidance on exposures and serve as surveillance systems for tracking real-world medication safety trends through the National Poison Data System.

🔬Are compounded semaglutide versions safe?

Compounded versions are not reviewed by the FDA for safety or efficacy in the same way as approved products and have been associated with dosing confusion during shortages.

📖Where can I read the full study?

The peer-reviewed paper appears in the Journal of Medical Toxicology and is available via PMC at pmc.ncbi.nlm.nih.gov/articles/PMC13076849.

🆘What is the contact for poison control help?

Call 1-800-222-1222 anytime for free, confidential assistance with medication questions or exposures.