Disproportionality analysis on semaglutide and nonarteritic anterior ischemic optic neuropathy in the FDA adverse event reporting system: An emerging pharmacovigilance signal?
Angela Procacci, Elisabetta Poluzzi, Fabrizio De Ponti, Emanuel Raschi
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引用次数: 0
Abstract
Background and aim: On January 17th 2025, the European Medicines Agency started a review on semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy (NAION); we gained insight into this potential association by appraising post-marketing reporting.
Methods: We queried the FDA Adverse Event Reporting System (up to December 2024) to retrieve cases of NAION reported with GLP-1 receptor agonists. Disproportionality analysis was performed by calculating the Reporting Odds Ratio (ROR) with 95 % confidence Interval (CI). Signal of Disproportionate Reporting (SDR) was defined by a lower limit of the 95 %CI> 1. To account for potential confounding by indication and channeling bias, active-comparator restricted design and disproportionality by therapeutic area were performed by comparing semaglutide vs other antidiabetic/antiobesity drugs, including SGLT2-inhibitors.
Results: 96 NAION cases were retrieved (83 to semaglutide), peaking 53 in last 3 months (18 from Denmark), with a median time to onset of 186 days. An SDR emerged only for semaglutide (ROR=17.57; 95 %CI=13.93-21.90), and remained significant across comparators and therapeutic indications.
Conclusions: Notwithstanding limitations, including inability to infer causality, the consistency of disproportionality against a wide range of confounders together with other observational evidence raised the hypothesis of a safety signal, especially from Denmark. The exponential reporting trend calls for urgent clarification of drug-, patient- and Country-related risk factors.
期刊介绍:
The aim of Obesity Research & Clinical Practice (ORCP) is to publish high quality clinical and basic research relating to the epidemiology, mechanism, complications and treatment of obesity and the complication of obesity. Studies relating to the Asia Oceania region are particularly welcome, given the increasing burden of obesity in Asia Pacific, compounded by specific regional population-based and genetic issues, and the devastating personal and economic consequences. The journal aims to expose health care practitioners, clinical researchers, basic scientists, epidemiologists, and public health officials in the region to all areas of obesity research and practice. In addition to original research the ORCP publishes reviews, patient reports, short communications, and letters to the editor (including comments on published papers). The proceedings and abstracts of the Annual Meeting of the Asia Oceania Association for the Study of Obesity is published as a supplement each year.