The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Semaglutide: Nonarteritic Anterior Ischemic Optic Neuropathy in the FDA adverse event reporting system – A disproportionality analysis
Abstract
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is used for type 2 diabetes (T2D) and approved for obesity by the FDA in 2022 and in Europe in 2023. Its increasing use has raised concerns about access for T2D patients and potential adverse events (AE), such as Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). This study investigates the association between semaglutide and these AE using the FDA Adverse Event Reporting System (FAERS). We conducted a disproportionality analysis using FAERS data. AE were identified using MedDRA Preferred Terms (PTs) and related terms. OpenVigil 2.1 was used for data extraction and analysis. This system is a spontaneous safety surveillance database for drugs. The participants are patients who reported AE related to GLP-1 receptor agonists in the FAERS database from January 1, 2004, to September 30, 2024. Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR) were calculated to assess the association between GLP-1 receptor agonists and the AE. Semaglutide showed a significant ROR and PRR for NAION, suggesting a stronger association compared to other GLP-1 receptor agonists. The findings suggest a disproportionate reporting signal for semaglutide and NAION. The mechanisms behind these associations are not fully understood but may involve effects on the hypothalamus and vascular health. Further research is necessary to confirm these findings ensure the safe use of semaglutide, given the potential risk associated with this rare but severe adverse event.
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“suggesting a potential causal relationship between semaglutide and NAION [98].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [98]
In the citing paper
“The FAERS database also revealed 41 reported cases for semaglutide with an ROR of 11.36 (95% CI, 8.33 to 15.49) and a PRR of 11.36 (95% CI, 8.32 to 15.47), suggesting a potential causal relationship between semaglutide and NAION [98].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [98]
Citations
Cites
Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide
Hathaway, J. T., Shah, M. P., Hathaway, D. B., Zekavat, S. M., Krasniqi, D., Gittinger, J. W., Cestari, D., Mallery, R., Abbasi, B., Bouffard, M., et al. (2024) · JAMA Ophthalmology · doi:10.1001/jamaophthalmol.2024.2296 · Cited by 318
Hernández, C., Bogdanov, P., Corraliza, L., García-Ramírez, M., Solà-Adell, C., Arranz, J. A., Arroba, A. I., Valverde, A. M., & Simó, R. (2016) · Diabetes · doi:10.2337/db15-0443 · Cited by 267
Mailhac, A., Pedersen, L., Pottegård, A., Søndergaard, J., Mogensen, T., Sørensen, H., & Thomsen, R. (2024) · Clinical Epidemiology · doi:10.2147/clep.s456170 · Cited by 60
Research works printed but not linked: 7
- Chiappini, 2023, Is there a risk for semaglutide misuse? Focus on the food and drug administration’s FDA adverse events reporting system (FAERS) pharmacovigilance dataset, Pharmaceuticals, 16, 994, 10.3390/ph16070994 · DOI · Paper page
- Impact of Semaglutide and Dulaglutide Shortages [Internet]. Australian Journal of General Practice. Available from: 〈https://www1.racgp.org.au/ajgp/2024/january-february/impact-of-semaglutide-and-dulaglutide-shortages〉. [cited 2024 Jul 23].
- Böhm, 2016, OpenVigil FDA - inspection of U.S. American Adverse drug events pharmacovigilance data and novel clinical applications, PLoS One, 11, 10.1371/journal.pone.0157753 · DOI
- Poluzzi E, Raschi E, Piccinni C, Ponti FD, Poluzzi E, Raschi E, Data Mining techniques in pharmacovigilance: analysis of the publicly accessible FDA Adverse Event Reporting System (AERS). Data Mining Applications in Engineering and Medicine [Internet]. IntechOpen; 2012. Available from: https://www.intechopen.com/chapters/38579. [cited 2023 Nov 6]. · DOI
- Evans, 2001, Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports, Pharmacoepidemiol Drug Saf, 10, 483, 10.1002/pds.677 · DOI
- Hölscher, 2012, Potential role of glucagon-like peptide-1 (GLP-1) in neuroprotection, CNS Drugs, 26, 871, 10.2165/11635890-000000000-00000 · DOI
- Prillaman, 2024, Obesity drugs aren’t always forever. What happens when you quit?, Nature, 628, 488, 10.1038/d41586-024-01091-8 · DOI
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Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning
Kim, J. A., & Yoo, H. J. (2025) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2025.0242 · Cited by 71
“The FAERS database also revealed 41 reported cases for semaglutide with an ROR of 11.36 (95% CI, 8.33 to 15.49) and a PRR of 11.36 (95% CI, 8.32 to 15.47), suggesting a potential causal relationship between semaglutide and NAION [98].”
Influential
Metadata
- Authors
- Azab, M., & Pasina, L.
- Affiliations
- Mario Negri Institute for Pharmacological Research (IT)
- Corresponding author
- Azab, Marina
- Venue
- Obesity Research & Clinical Practice
- Publisher
- Elsevier BV
- Published
- 2025-01
- Volume
- 19
- Issue
- 1
- Pages
- 77-79
- ISSN
- 1871-403X (ISSN-L)
- OpenAlex
- W4407237913
- Cited by
- 33
- References
- 3
- Citations by year
- 2026: 18 · 2025: 15
- FWCI
- 16.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Obesity Research & Clinical Practice (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Ophthalmology › Drug-Induced Ocular Toxicity
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- semaglutide, nonarteritic anterior ischemic optic neuropathy, GLP-1 receptor agonists, drug safety, adverse drug reactions, disproportionality analysis, FDA Adverse Event Reporting System, type 2 diabetes, obesity, reporting odds ratio, proportional reporting ratio
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Glucagon-Like Peptide-1 Receptor Agonists, Semaglutide, Adult, Aged, Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, United States, United States Food and Drug Administration, Databases, Factual, Adverse Drug Reaction Reporting Systems, Optic Neuropathy, Ischemic, Glucagon-Like Peptide 1
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