June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Food and Drug Administration Adverse Event Reports of Diabetic Retinopathy, Macular Edema and Blurred Vision Associated with GLP-1 Receptor Agonist Use
Author Affiliations & Notes
  • Grace Xiao
    Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
  • Albert Li
    University of Maryland School of Medicine, Maryland, United States
  • Footnotes
    Commercial Relationships   Grace Xiao, None; Albert Li, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 290. doi:
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      Grace Xiao, Albert Li; Food and Drug Administration Adverse Event Reports of Diabetic Retinopathy, Macular Edema and Blurred Vision Associated with GLP-1 Receptor Agonist Use. Invest. Ophthalmol. Vis. Sci. 2020;61(7):290.

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Abstract

Purpose : GLP-1 receptor agonists are commonly prescribed to improve glycemic control in type 2 diabetes, but the risk of adverse ocular events is unclear. Secondary analysis of the SUSTAIN-6 clinical trial of Ozempic (semaglutide) found a significant increased risk of diabetic retinopathy for patients taking the drug so we investigated whether this is reflected in adverse ocular event reports of Ozempic and other GLP-1 drugs in the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods : We surveyed all adverse effects associated with GLP-1 receptor agonists (semaglutide, albiglutide, dulaglutide, and liraglutide) recorded in the Food and Drug Administration Adverse Event Reporting System (FAERS) to quantify the prevalence of ocular adverse events including diabetic retinopathy, macular edema and blurred vision. University of Maryland Institutional Review Board deemed use of this anonymized database to be exempt.

Results : Among 2109 adverse events associated with Ozempic since 2018, there were 140 adverse ocular events of note, with 23 cases of diabetic retinopathy, 4 cases of macular complications, and 47 cases of blurred vision. The percentage of reported diabetic retinopathy out of adverse ocular events and total events is significantly higher for Ozempic (16.4% and 1.1%) compared to other GLP-1 medications like Tanzeum (4.5% and 0.05%), Trulicity (2.3% and 0.06%) and Victoza (4.1% and 0.09%) as well as common diabetes medications like metformin (6.3% and 0.19%).

Conclusions : We analyzed adverse ocular events recorded in the FDA Adverse Event Reporting System and found that the use of Ozempic is associated with higher rates of diabetic retinopathy and adverse ocular events compared to other GLP-1 receptor agonists. Since FAERS data does not have sufficient information to determine the causal relationship between Ozempic and adverse ocular events, further research is necessary to further characterize this association. A more thorough understanding of the link between GLP-1 agonists and ocular outcomes would make it possible to better treat patients with type II diabetes while preventing unintended ophthalmic consequences.

This is a 2020 ARVO Annual Meeting abstract.

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