FDA requires GLP-1 labeling update for potential eye condition risk

The Food and Drug Administration says, in a November 9 announcement, it is requiring labeling changes for GLP-1 receptor agonists to address a potential increased risk of a rare eye condition.

The requirement applies to application holders for all medications in the class, the agency said Monday, November 9. They must add information about the potential risk to the Warnings and Precautions section of the labeling.

The FDA describes the condition, non-arteritic anterior ischemic optic neuropathy, or NAION, as rare and says it can include permanent vision loss. The agency describes the potential increased risk as associated with use of the medications.

A 2024 medical paper prompted further assessment, the FDA said, although it identified limitations in that study. The agency’s evaluation included clinical-trial and postmarketing evidence, including observational studies and case reports.

CBS News spoke Monday with Dr. Joseph Rizzo, a neuro-ophthalmologist and co-author of the paper. He said his team had worked with the FDA gathering and reviewing data. Rizzo said the warning decision did not surprise him, though he had not known the agency was ready to decide.