FDA mandates vision-loss warning on GLP-1 drug labels

The U.S. Food and Drug Administration announced that labels for all GLP-1 receptor agonists, including Ozempic, Wegovy, Zepbound and Mounjaro, must now contain a warning about a possible rare eye condition that can lead to permanent vision loss. The warning covers drugs used for obesity, diabetes and other medical conditions and applies to both injectable and oral forms.

The condition, non-arteritic anterior ischemic optic neuropathy (NAION), results from reduced blood flow to the optic nerve and can cause blurred vision, blind spots and distorted colours. The FDA said the underlying cause of NAION is unknown.

The labeling change follows a 2024 study that reviewed more than 125 clinical trials and FDA’s own adverse-event reporting system, which together indicated the risk occurs in roughly six of every 100,000 patients after at least one year of GLP-1 use. The agency concluded there is a “potential increased risk of rare NAION events in patients taking GLP-1 RAs.”

“Based on these findings, FDA is requiring that application holders add information about the risk for NAION to the Warnings and Precautions section of labeling of all GLP-1 RAs,” the agency stated.

Health Canada recently flagged a similar safety concern for Ozempic, Rybelsus and Wegovy, though its review findings have not yet been published. Other recent studies have highlighted both potential benefits, such as reduced cancer risk, and additional side effects, including a modest increase in hair-loss risk among GLP-1 users.