Ozempic: FDA Orders GLP-1 Labeling Changes Due to Eye Disease Risk

The Food and Drug Administration (FDA) announced on November 9 that it will require drugmakers to add information to the warning labels of Ozempic, Wegovy, Mounjaro, Zepbound and other GLP-1 medications about “a potential increased risk” of a rare eye condition called nonarteritic anterior ischemic optic neuropathy (NAION).

GLP-1 medications are approved to treat type 2 diabetes and to help people lose weight and keep it off.

NAION joins a growing list of side effects linked to GLP-1s, adding a second eye warning to several labels.

The U.S. labels for Ozempic, Rybelsus, Trulicity, Mounjaro, and Zepbound already warn about diabetic retinopathy, a diabetes-related eye disease, according to each drug’s prescribing information.

The two conditions affect different parts of the eye. Diabetic retinopathy damages tiny blood vessels in the retina, the layer at the back of the eye that senses light, according to the National Eye Institute. NAION damages the optic nerve when it doesn’t get enough blood, according to the FDA’s announcement.

Mihail Zilbermint, MD, director of endocrine hospitalists at Johns Hopkins, told Healthline he hasn’t seen NAION in his patients. He has seen vision worsen in some people after they start a GLP-1.

“But we believe that’s probably related to rapid improvement in their sugar control, which can also be seen in someone who is starting insulin,” Zilbermint said.