Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies
Open accessAbstract
Background & aims Glucagon-like peptide-1-based therapy is gaining widespread use for type 2 diabetes, although there are concerns about risks for pancreatitis and pancreatic and thyroid cancers. There are also concerns that dipeptidyl peptidase-4 inhibitors could cause cancer, given their effects on immune function.Methods We examined the US Food and Drug Administration's database of reported adverse events for those associated with the dipeptidyl peptidase-4 inhibitor sitagliptin and the glucagon-like peptide-1 mimetic exenatide, from 2004-2009; data on adverse events associated with 4 other medications were compared as controls. The primary outcomes measures were rates of reported pancreatitis, pancreatic and thyroid cancer, and all cancers associated with sitagliptin or exenatide, compared with other therapies.Results Use of sitagliptin or exenatide increased the odds ratio for reported pancreatitis 6-fold as compared with other therapies (P<2×10(-16)). Pancreatic cancer was more commonly reported among patients who took sitagliptin or exenatide as compared with other therapies (P<.008, P<9×10(-5)). All other cancers occurred similarly among patients who took sitagliptin compared with other therapies (P=.20).Conclusions These data are consistent with case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1-based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer.
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Pharmacovigilance databases reflect nonsubstantiated events reported by individuals and attributed to a particular drug; they do not establish a causal or even an association relationship between a drug and the event, serving instead for hypothesis generation.
“However, these databases reflect nonsubstantiated events reported by individuals and attributed—by those individuals—to a particular drug.61–63 They do not establish a causal or even an association relationship between a drug and the event, serving instead for hypothesis generation and prompt for future investigation of disproportional increased reporting of events.”
From Glucagon-Like Peptide-1 Receptor Agonists and Thyroid Cancer: A Narrative Review (2024) · cites this paper as [62]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn an analysis of the U.S. FDA database, the OR was 4.73 for a report of a thyroid cancer event for exenatide compared with comparators (rosiglitazone, nateglinide, repaglinide, and glipizide) (p = 0.004).
“In their analysis, they found an OR = 4.73 for a report of a thyroid cancer event for exenatide compared with comparators (rosiglitazone, nateglinide, repaglinide, and glipizide) (p = 0.004).62”
From Glucagon-Like Peptide-1 Receptor Agonists and Thyroid Cancer: A Narrative Review (2024) · cites this paper as [62]
The Results (Thyroid cancer; page unavailable) report an OR of 4.73 and P = 0.004 for reported thyroid cancer with exenatide in the FDA adverse-event database. The Methods (Study Design; page unavailable) name all four drugs as controls, but the thyroid-cancer Results specify rosiglitazone as the comparator for this analysis, not the four-drug group stated in the claim. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn that report, the incidence of pancreatic cancer was 2.9 and 2.7 times greater with exenatide and sitagliptin, respectively, compared to other oral antidiabetic medications.
“In that report, the incidence of pancreatic cancer was also 2.9 and 2.7 times greater with exenatide and sitagliptin, respectively, compared to other oral antidiabetic medications.”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [51]
The Results (Pancreatic cancer) give the claimed 2.9-fold and 2.7-fold comparisons for exenatide and sitagliptin. But these are rates of reported adverse events, not measured pancreatic-cancer incidence; the Methods describe the FDA adverse-event reporting database, and the Discussion notes its reporting biases. (LLM, conf=0.88)
Experimental — accuracy not yet measuredInitial observational signals from 2011 suggested an increased risk of acute pancreatitis and pancreatic cancer in patients using GLP-based therapies compared to non-users (adjusted OR 2.24, 95% CI 1.36, 3.68).
“Initial observational signals from 2011 suggested an increased risk of acute pancreatitis and pancreatic cancer in patients using GLP-based therapies compared to non-users (adjusted odds ratio [OR]: 2.24, 95% CI 1.36, 3.68),67,68 leading the FDA to issue a warning on the pancreatic safety of GLP-1 RAs.69”
From The expanding role of GLP-1 receptor agonists: a narrative review of current evidence and future directions (2025) · cites this paper as [67]
The Results (page not available in our copy) report more frequent adverse-event reports of pancreatitis and pancreatic cancer with exenatide or sitagliptin than with other diabetes therapies. They do not report the claimed adjusted OR of 2.24 (95% CI 1.36–3.68), and the comparator was other therapies, not non-users. The paper cautions that its retrospective reporting analysis cannot fully account for confounding. (LLM, conf=0.90)
Experimental — accuracy not yet measuredSearches of adverse event-reporting databases indicated a substantially higher risk for acute pancreatitis with GLP-1RA treatment.
“The case reports of pancreatitis prompted searches of adverse event–reporting databases (65), which indicated a substantially higher risk for acute pancreatitis with GLP-1RA treatment.”
From The science of safety: adverse effects of GLP-1 receptor agonists as glucose-lowering and obesity medications (2026) · cites this paper as [65]
The Results (Control Events, Pancreatitis) report substantially more frequent pancreatitis adverse-event reports for exenatide and sitagliptin than for comparator therapies. The Discussion cautions that the FDA AERS database has reporting biases and is not ideal for comparing adverse-event rates. The finding therefore supports a reporting signal, not an established higher clinical risk; it also combines exenatide with sitagliptin rather than examining GLP-1 receptor agonists alone. (LLM, conf=0.86)
Experimental — accuracy not yet measured
With GLP-1RA, case reports and adverse event database studies first signaled acute kidney injury, pancreatitis, pancreatic cancer and thyroid cancer.
“With GLP-1RA, these encompassed AKI, pancreatitis, pancreatic cancer and thyroid cancer”
From Safety of Semaglutide (2021) · cites this paper as [6]
The Results (page unavailable) report adverse-event signals for pancreatitis, pancreatic cancer, and thyroid cancer with exenatide, a GLP-1 receptor agonist; the Discussion identifies the FDA adverse-event database as the source of the analysis. The paper also mentions earlier case reports of acute pancreatitis, but our copy does not report an acute kidney injury signal. Its analysis includes sitagliptin, a DPP-4 inhibitor, as well as exenatide. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAn analysis of the US FDA adverse events database from 2004 to 2009 revealed a six-fold increase in pancreatitis incidents linked to sitagliptin and exenatide.
“From 2004 to 2009, an analysis of the database revealed a six-fold increase in pancreatitis incidents linked to the DPP-4 inhibitor sitagliptin and the GLP-1 mimetic exenatide, the first two GLP-1-based medications marketed in the US [51].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [51]
GLP-1RAs are associated with adverse effects including pancreatitis, pancreatic cancer and thyroid cancer initially flagged as safety alerts.
“However, partly due to the widespread presence of GLP-1 receptors, several adverse effects have been observed, of which pancreatitis, pancreatic cancer and thyroid cancer were initially flagged as safety alerts (6).”
From Safety of Semaglutide (2021) · cites this paper as [6]
Human studies did not confirm the rodent findings of increased pancreatic, intestinal, and breast neoplasms with incretin-based medications.
“these results were not confirmed in human studies [56–58].”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [58]
In rodents, incretin-based medications were associated with more pancreatic, intestinal, and breast neoplasms.
“Pancreatic, intestinal, and breast neoplasms were more frequently developed in rodents administered with incretin-based medications”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [58]
GLP-1 receptor agonist use may be associated with an increased risk of acute pancreatitis and thyroid cancer.
“In addition, GLP-1RAs use may be associated with an increased risk of acute pancreatitis and thyroid cancer, and the FDA has warned the public about these AEs (10–12).”
From Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system (2022) · cites this paper as [12]
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- Authors
- Elashoff, M., Matveyenko, A. V., Gier, B., Elashoff, R., & Butler, P. C.
- Affiliations
- University of California, Los Angeles (US)
- Corresponding author
- Butler, Peter C.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2011-07
- Volume
- 141
- Issue
- 1
- Pages
- 150-156
- ISSN
- 0016-5085 (ISSN-L)
- PMC
- PMC4404515
- OpenAlex
- W2112981414
- Cited by
- 944
- References
- 40
- Citations by year
- 2026: 48 · 2025: 61 · 2024: 61 · 2023: 33 · 2022: 53 · 2021: 40 · 2020: 28 · 2019: 38 · 2018: 44 · 2017: 47 · 2016: 64 · 2015: 70 · 2014: 101 · 2013: 130 · 2012: 87
- FWCI
- 92.76
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Larry L. Hillblom Foundation
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK077967)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
- Keywords
- GLP-1 receptor agonists, sitagliptin, exenatide, DPP-4 inhibitors, pancreatitis, pancreatic cancer, thyroid cancer, drug-induced cancer risk, adverse drug reactions, type 2 diabetes
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Sitagliptin Phosphate, Exenatide, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Pancreatic Neoplasms, Pancreatitis, Peptides, Pyrazines, Risk Factors, Thyroid Neoplasms, Triazoles, United States, United States Food and Drug Administration, Venoms, Odds Ratio, Adverse Drug Reaction Reporting Systems, Receptors, Glucagon, Risk Assessment, Dipeptidyl-Peptidase IV Inhibitors
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