{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T09:13:45Z","timestamp":1788426825744,"version":"build-2803163510"},"reference-count":51,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To characterise postmarketing safety signals and medication\u2010use risks associated with GLP\u20101 receptor agonists and the GIP\/GLP\u20101 co\u2010agonist tirzepatide in diabetes and obesity care using an integrated pharmacovigilance, utilisation\u2010context, regulatory, and external\u2010consistency framework.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>FDA Adverse Event Reporting System (FAERS) data from 2021Q1 through 2026Q1 were processed using deleted\u2010case exclusion, latest\u2010case\u2010version retention, and case\u2010product deduplication with analysis at the GLP\u20101 primary\u2010suspect case\u2010product level. Primary\u2010suspect 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\u2010Related Labelling Changes resources, FDA shortage and compounded\u2010product communications, and Canada Vigilance reports provided contextual interpretation; no data source was used to estimate incidence, comparative risk, or causality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The final FAERS analysis set included 243\u2009114 GLP\u20101 primary\u2010suspect case\u2010product records within 8\u2009995\u2009547 background reports. Tirzepatide accounted for 133\u2009100 records, followed by semaglutide (55619) and dulaglutide (38406). Frequently reported terms included incorrect dose administered, nausea, injection\u2010site pain, diarrhoea, vomiting, off\u2010label use, and extra dose administered. Prioritised domains included gastrointestinal intolerance, medication\u2010use\/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\u2010use terms reflected use\u2010process rather than conventional adverse\u2010drug\u2010reaction issues.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Multi\u2010source pharmacovigilance can improve interpretation of GLP\u20101 postmarketing safety evidence in diabetes and obesity care. Findings should be interpreted as signal\u2010prioritisation and medication\u2010safety evidence, not as incidence, proof of causality, or population\u2010level comparative risk, given the limited clinical interpretability of spontaneous\u2010reporting data.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.71303","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T08:22:32Z","timestamp":1788423752000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Postmarketing Safety Signals and Medication\u2010Use Risks of\n                    <scp>GLP<\/scp>\n                    \u20101\u2010Based Therapies in Diabetes and Obesity: A Multi\u2010Source Pharmacovigilance and Regulatory Evidence\u2010Mapping Study"],"prefix":"10.1111","author":[{"given":"Long","family":"Ren","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Shanghai East Hospital Tongji University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shanghai East Hospital Tongji University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Fang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shanghai East Hospital Tongji University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-6133-7999","authenticated-orcid":false,"given":"Yabin","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shanghai East Hospital Tongji University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,3]]},"reference":[{"key":"e_1_2_12_2_1","volume-title":"Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII","author":"Council for International Organizations of Medical Sciences","year":"2010"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3701"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.3389\/fdsfr.2023.1323057"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1488725"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2022.1043789"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.996179"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1397029"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40618\u2010024\u201002441\u2010z"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1416985"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010025\u201001206\u20109"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph16070994"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2024.2430306"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2025.2499670"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/haschl\/qxag023"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj\u20102024\u2010080340"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2026.4722"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000003760"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/edm2.70113"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm14217678"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph19010136"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(07)61602\u2010X"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2025.1573353"},{"key":"e_1_2_12_24_1","unstructured":"U.S. Food and Drug Administration \u201cFDA Adverse Event Reporting System (FAERS) Public Dashboard and Quarterly Data Files \u201daccessed July 7 2026."},{"issue":"6","key":"e_1_2_12_25_1","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1002\/pds.677","article-title":"Use of Proportional Reporting Ratios (PRRs) for Signal Generation From Spontaneous Adverse Drug Reaction Reports","volume":"10","author":"Evans S. 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