Assessing the Association Between GLP-1 Receptor Agonist Use and Diabetic Retinopathy Through the FDA Adverse Event Reporting System

Recently, the Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN-6) suggested that semaglutide may increase the risk for diabetic retinopathy (DR) adverse events (AEs) compared with placebo. Other trials of glucagon-like peptide 1 receptor agonists (GLP-1RA) showed a numerically higher incidence of DR AEs for liraglutide but not exenatide. However, these trials did not systematically assess DR. Our population-based cohort study of older U.S. adults suggested that GLP-1RA use for approximately 1 year does not increase DR risk (1). As current evidence on GLP-1RA–associated DR risk is still limited, we conducted a disproportionality analysis of the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to examine the association between GLP-1RA and DR events. We used generic and brand names to identify GLP-1RA (exenatide, liraglutide, albiglutide, and dulaglutide) and comparator drugs in the FAERS database and Medical Dictionary for Regulatory Activities (MedDRA v21.0) preferred terms to identify DR cases (diabetic retinopathy, retinopathy, macular edema, retinopathy proliferative, retinopathy hemorrhagic, blindness, vitreous hemorrhage) from 28 April 2005 (approval date for the first GLP-1RA, exenatide) to 30 September 2017. We performed a disproportionality analysis using the reporting odds ratio (ROR) to assess whether there is a signal for a potentially increased risk of DR among GLP-1RA users. The ROR is calculated by …