The U.S. Food and Drug Administration is requiring new safety warnings for Ozempic and other GLP-1 medications over a potential increased risk of a rare eye condition.

The condition, known as non-arteritic anterior ischemic optic neuropathy, or NAION, occurs when blood flow to the optic nerve is reduced. It can cause sudden, painless vision loss, typically in one eye, and there is currently no known treatment to reverse the damage.

The FDA said its review of 126 randomized, controlled clinical trials found approximately 6.4 cases of NAION per 100,000 person-years among patients taking GLP-1 medications, compared with 3.8 cases among those taking a placebo or other non-GLP-1 diabetes medication. The agency said the condition remains rare but concluded that there is a potential increased risk associated with the medications.

The warning will apply to the entire GLP-1 drug class, including Novo Nordisk's Ozempic and Wegovy, as well as Mounjaro and Zepbound. The FDA said cases of NAION have been reported with all currently marketed GLP-1 medications.

Patients taking these medications are advised to immediately report sudden vision loss, changes in their visual field or other visual disturbances in one eye and seek medical evaluation.

The FDA's action follows research examining a possible connection between semaglutide, the active ingredient in Ozempic and Wegovy, and NAION. However, Novo Nordisk said the available evidence does not establish that GLP-1 medications cause the condition and said it remains confident in the benefit-risk profile of its medications.

The FDA's new warning is separate from other existing safety warnings for Ozempic, including its boxed warning concerning the potential risk of thyroid C-cell tumors.

This article was independently written by the BJL Newsroom based on information from the U.S. Food and Drug Administration and additional published reports.