Association between GLP-1RA and retinal AEs in the FAERS
| Adverse event, n (/1000) | Model 1 | Model 2 | ||||
| GLP-1RA (n=114 814) | Control (n=694 725) | PRR (95% CI) | GLP-1RA (n=79 165) | Control (n=360 132) | PRR (95% CI) | |
| Retinal injury | 1 (0.01) | 65 (0.09) | 0.09 (0.01 to 0.67) | 1 (0.01) | 40 (0.11) | 0.11 (0.02 to 0.83) |
| Retinal vascular disorder | 1 (0.01) | 64 (0.09) | 0.09 (0.01 to 0.68) | 0 (0.00) | 27 (0.07) | N/D |
| Retinal scar | 1 (0.01) | 63 (0.09) | 0.10 (0.01 to 0.69) | 1 (0.01) | 29 (0.08) | 0.16 (0.02 to 1.15) |
| Retinal tear | 3 (0.03) | 133 (0.19) | 0.14 (0.04 to 0.43)* | 1 (0.01) | 56 (0.16) | 0.08 (0.01 to 0.59) |
| Retinal operation | 1 (0.01) | 28 (0.04) | 0.22 (0.03 to 1.59) | 1 (0.01) | 19 (0.05) | 0.24 (0.03 to 1.79) |
| Retinal ischemia | 1 (0.01) | 28 (0.04) | 0.22 (0.03 to 1.59) | 1 (0.01) | 14 (0.04) | 0.32 (0.04 to 2.47) |
| Retinopathy | 28 (0.24) | 760 (1.09) | 0.22 (0.15 to 0.33)* | 23 (0.29) | 427 (1.19) | 0.25 (0.16 to 0.37)* |
| Retinal exudates | 4 (0.03) | 104 (0.15) | 0.23 (0.09 to 0.63) | 4 (0.05) | 47 (0.13) | 0.39 (0.14 to 1.07) |
| Retinal aneurysm | 3 (0.03) | 76 (0.11) | 0.24 (0.08 to 0.76) | 3 (0.04) | 40 (0.11) | 0.34 (0.11 to 1.10) |
| Retinal artery occlusion | 3 (0.03) | 73 (0.11) | 0.25 (0.08 to 0.79) | 2 (0.03) | 26 (0.07) | 0.35 (0.08 to 1.47) |
| Retinal neovascularization | 1 (0.01) | 21 (0.03) | 0.29 (0.04 to 2.14) | 1 (0.01) | 7 (0.02) | 0.65 (0.08 to 5.28) |
| Retinal vein occlusion | 9 (0.08) | 150 (0.22) | 0.36 (0.19 to 0.71) | 7 (0.09) | 68 (0.19) | 0.47 (0.22 to 1.02) |
| Retinal hemorrhage | 49 (0.43) | 800 (1.15) | 0.37 (0.28 to 0.49)* | 19 (0.24) | 376 (1.04) | 0.23 (0.14 to 0.36)* |
| Retinal detachment | 43 (0.37) | 697 (1.00) | 0.37 (0.27 to 0.51)* | 27 (0.34) | 405 (1.12) | 0.30 (0.21 to 0.45)* |
| Retinal disorder | 19 (0.17) | 277 (0.40) | 0.42 (0.26 to 0.66)* | 17 (0.21) | 158 (0.44) | 0.49 (0.30 to 0.81) |
| Diabetic retinopathy | 122 (1.06) | 1663 (2.39) | 0.44 (0.37 to 0.53)* | 92 (1.16) | 960 (2.67) | 0.44 (0.35 to 0.54)* |
| Diabetic retinal edema | 8 (0.07) | 108 (0.16) | 0.45 (0.22 to 0.92) | 3 (0.04) | 47 (0.13) | 0.29 (0.09 to 0.93) |
| Retinal edema | 12 (0.10) | 115 (0.17) | 0.63 (0.35 to 1.14) | 9 (0.11) | 57 (0.16) | 0.72 (0.36 to 1.45) |
| Retinal vascular thrombosis | 5 (0.04) | 45 (0.06) | 0.67 (0.27 to 1.69) | 5 (0.06) | 21 (0.06) | 1.08 (0.41 to 2.87) |
| Retinopathy proliferative | 6 (0.05) | 46 (0.07) | 0.79 (0.34 to 1.85) | 3 (0.04) | 31 (0.09) | 0.44 (0.13 to 1.44) |
| Retinogram abnormal | 2 (0.02) | 13 (0.02) | 0.93 (0.21 to 4.13) | 2 (0.03) | 4 (0.01) | 2.27 (0.42 to 12.42) |
| Retinal artery embolism | 3 (0.03) | 10 (0.01) | 1.82 (0.50 to 6.60) | 3 (0.04) | 3 (0.01) | 4.55 (0.92 to 22.54) |
| Retinopathy hemorrhagic | 4 (0.03) | 10 (0.01) | 2.42 (0.76 to 7.72) | 4 (0.05) | 5 (0.01) | 3.64 (0.98 to 13.55) |
| Retinopexy | 3 (0.03) | 2 (0.00) | 9.08 (1.52 to 54.32) | 3 (0.04) | 1 (0.00) | 13.7 (1.4 to 131.2) |
| Pooled | 291 (2.53) | 4597 (6.62) | 0.38 (0.34 to 0.43) | 214 (2.70) | 2528 (7.02) | 0.39 (0.34 to 0.44) |
Number of reports, rates/1000 reports, and PRR (with 95% CIs) are shown for model 1 (no diabetes indication) and model 2 (filtered by diabetes indication).
*Significant after Bonferroni correction.
AE, adverse event; FAERS, Food and Drug Administration Adverse Event Reporting System; GLP-1RA, glucagon-like peptide-1 receptor agonists; N/D, not determined; PRR, proportional reporting ratio.