FDA Requires New Safety Warning on GLP-1 Medications for Rare Eye Condition

The FDA is requiring updated safety labeling for glucagon-like peptide-1 receptor agonists (GLP-1 RAs) to warn about a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can cause sudden vision loss.

According to the agency, NAION can cause acute, painless vision loss in one eye and may result in permanent vision impairment. The FDA said reports of NAION have been identified across currently marketed GLP-1 medications, which are widely used to treat type 2 diabetes and obesity.

The labeling change follows an FDA review of clinical trial data, observational studies and postmarketing safety reports. The agency concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 medications and is requiring manufacturers to add information about that risk to the Warnings and Precautions section of product labeling.

The warning applies to GLP-1 medications including Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound and Foundayo, among others.

The FDA advises patients taking GLP-1 medications to contact their health care professional immediately if they experience sudden vision loss, blind spots, tunnel vision or other significant changes in vision. Health care professionals are advised to promptly refer patients with suspected NAION for ophthalmologic evaluation and consider whether continuing treatment is appropriate.