Potential Risk of Acute Pancreatitis With GLP-1 Receptor Agonists
Author(s)
Hadir Aljohani, Master.
SFDA, riyadh, Saudi Arabia.
SFDA, riyadh, Saudi Arabia.
OBJECTIVES: The risk of acute pancreatitis has been reported with use of all GLP-1 receptor agonists. Given the severity of this adverse event, this review aims to evaluate the necessity of implementing additional risk minimization measures (RMM) specifically targeted at the risk of acute pancreatitis associated with these medications.
METHODS: We conducted a systematic search across multiple databases, including PubMed, Google Scholar, and ClinicalTrials.gov, from 2023 to April 2025 to assess the necessity of RMM for acute pancreatitis associated with GLP-1 receptor agonists. Additionally, on March, 2025, we retrieved data from the World Health Organization (WHO) database (VigiBase) and the local adverse drug events database at the Saudi Food and Drug Authority (SFDA) regarding reported cases of GLP-1 receptor agonist-induced acute pancreatitis. Finally, we reviewed regulatory documents submitted to the SFDA, particularly the "Periodic Benefit Risk Evaluation Report".
RESULTS: Our search identified two interventional studies, seven observational studies, and ten case reports on the risk of acute pancreatitis linked to GLP-1 receptor agonists. Six local cases were noted: three with liraglutide, two with dulaglutide, and one with semaglutide. Only one case each of dulaglutide and liraglutide showed a possible relationship due to reasonable temporal associations; the others were unassessable due to insufficient data. In VigiBase, 8,889 cases were associated with GLP-1 receptor agonists, with 100 cases having a completeness score of ≥0.8 (including liraglutide, tirzepatide, and lixisenatide). Among the 25 highest completeness cases (dulaglutide and semaglutide), 92 were deemed possibly related, while eight were unassessable.
CONCLUSIONS: Given the findings from our review, the SFDA recommended issuing a Direct Healthcare Professional Communication (DHPC) from marketing companies to inform healthcare providers about serious adverse events linked to GLP-1 receptor agonists, especially the risk of pancreatitis.
METHODS: We conducted a systematic search across multiple databases, including PubMed, Google Scholar, and ClinicalTrials.gov, from 2023 to April 2025 to assess the necessity of RMM for acute pancreatitis associated with GLP-1 receptor agonists. Additionally, on March, 2025, we retrieved data from the World Health Organization (WHO) database (VigiBase) and the local adverse drug events database at the Saudi Food and Drug Authority (SFDA) regarding reported cases of GLP-1 receptor agonist-induced acute pancreatitis. Finally, we reviewed regulatory documents submitted to the SFDA, particularly the "Periodic Benefit Risk Evaluation Report".
RESULTS: Our search identified two interventional studies, seven observational studies, and ten case reports on the risk of acute pancreatitis linked to GLP-1 receptor agonists. Six local cases were noted: three with liraglutide, two with dulaglutide, and one with semaglutide. Only one case each of dulaglutide and liraglutide showed a possible relationship due to reasonable temporal associations; the others were unassessable due to insufficient data. In VigiBase, 8,889 cases were associated with GLP-1 receptor agonists, with 100 cases having a completeness score of ≥0.8 (including liraglutide, tirzepatide, and lixisenatide). Among the 25 highest completeness cases (dulaglutide and semaglutide), 92 were deemed possibly related, while eight were unassessable.
CONCLUSIONS: Given the findings from our review, the SFDA recommended issuing a Direct Healthcare Professional Communication (DHPC) from marketing companies to inform healthcare providers about serious adverse events linked to GLP-1 receptor agonists, especially the risk of pancreatitis.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD76
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)