Postmarketing Safety Signals and Medication-Use Risks of GLP-1-Based Therapies in Diabetes and Obesity: A Multi-Source Pharmacovigilance and Regulatory Evidence-Mapping Study.
This study highlights various safety signals associated with GLP-1 receptor agonists, including dulaglutide, but does not establish incidence or causality from the reported events.
Where it sits
this study against the rest of the dulaglutide corpusSummary and findings
This study analyzed postmarketing safety signals and medication-use risks associated with GLP-1 receptor agonists, including dulaglutide, using FDA Adverse Event Reporting System data from 2021Q1 to 2026Q1. A total of 243,114 GLP-1 primary-suspect case-product records were included, with dulaglutide accounting for 38,406 records. The study aimed to characterize adverse events and medication-use risks rather than establish incidence or causality.
Abstract
<h4>Aims</h4>To characterise postmarketing safety signals and medication-use risks associated with GLP-1 receptor agonists and the GIP/GLP-1 co-agonist tirzepatide in diabetes and obesity care using an integrated pharmacovigilance, utilisation-context, regulatory, and external-consistency framework.<h4>Materials and methods</h4>FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted-case exclusion, latest-case-version retention, and case-product deduplication with analysis at the GLP-1 primary-suspect case-product level. Primary-suspect records for semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, and lixisenatide were analysed using reporting odds ratios, proportional reporting ratios, and an approximate Information Component. Medicaid utilisation data, FDA labelling/Safety-Related Labelling Changes resources, FDA shortage and compounded-product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.<h4>Results</h4>The final FAERS analysis set included 243 114 GLP-1 primary-suspect case-product records within 8 995 547 background reports. Tirzepatide accounted for 133 100 records, followed by semaglutide (55619) and dulaglutide (38406). Frequently reported terms included incorrect dose administered, nausea, injection-site pain, diarrhoea, vomiting, off-label use, and extra dose administered. Prioritised domains included gastrointestinal intolerance, medication-use/device events, impaired gastric emptying, pancreatobiliary events, renal/dehydration events, and hypoglycaemia. Canada Vigilance and FDA labelling/SrLC mapping showed descriptive visibility for most major domains, while medication-use terms reflected use-process rather than conventional adverse-drug-reaction issues.<h4>Conclusions</h4>Multi-source pharmacovigilance can improve interpretation of GLP-1 postmarketing safety evidence in diabetes and obesity care. Findings should be interpreted as signal-prioritisation and medication-safety evidence, not as incidence, proof of causality, or population-level comparative risk, given the limited clinical interpretability of spontaneous-reporting data.
Background
Not reported in abstract.
Methods
Not reported in abstract.
Results
Not reported in abstract.
Interpretation
Not reported in abstract.
Limitations
Not reported in abstract.