The article examines the objective, findings, and clinical context described in FDA flags vision loss risk with GLP-1 drugs.
Approach:
Safety action: The FDA directed manufacturers to add NAION risk information to the Warnings and Precautions section of prescribing information for all marketed GLP-1 receptor agonists.
Evidence reviewed: The FDA reviewed clinical trials, observational studies, postmarketing reports, and animal data, and conducted a Sentinel database cohort study of adults with type 2 diabetes who initiated GLP-1, SGLT2, or DPP4 inhibitors between 2019 and 2024.
Key Findings:
In a meta-analysis of 126 randomized trials involving 134,253 patients, 15 probable NAION cases were identified: 10 among 78,217 GLP-1 RA recipients and 5 among 56,036 comparator recipients; all comparator cases occurred in placebo groups.
Estimated NAION incidence in the meta-analysis was 6.4 per 100,000 person-years with GLP-1 RAs and 3.8 with comparators.
In the Sentinel study, incidence ranged from 30 to 32 cases per 100,000 person-years with GLP-1 RAs, compared with 31 for SGLT2 inhibitors and 26 for DPP4 inhibitors. Risk was significantly higher versus DPP4 inhibitors, but not versus SGLT2 inhibitors.
The FDA reported NAION cases with all currently marketed GLP-1 RAs. Its animal-data review did not identify a mechanism explaining the potential increased risk.
Interpretation:
The FDA described a potential increased risk of NAION, a rare condition that can cause sudden, painless, potentially permanent vision loss. It noted that postmarketing reports are difficult to interpret because NAION risk factors overlap with conditions common among GLP-1 RA users.
Limitations:
The FDA said overlapping risk factors, including diabetes, hypertension, and sleep apnea, complicate interpretation of postmarketing reports.
The animal-data review did not identify a mechanism explaining the potential risk.
Conclusion:
The FDA advises health care professionals to tell patients to report sudden, painless visual changes immediately and to promptly refer suspected NAION cases for ophthalmologic evaluation. It recommends considering GLP-1 RA discontinuation after NAION unless treatment benefits clearly outweigh risks.
Investigators examined Life’s Essential 8 scores and carotid ultrasonography measures across cardiovascular-kidney-metabolic stages in 1,283 young adults.
