FDA warns of rare eye condition causing blindness from GLP-1 weight loss medications

The US Food and Drug Administration (FDA) has issued a warning regarding a rare eye condition called nonarteritic anterior ischemic optic neuropathy (NAION) that could lead to sudden and permanent blindness among patients using GLP-1 weight loss medications. These medications, which include Novo Nordisk's Ozempic and Wegovy, Eli Lilly's Mounjaro and Zepbound, and Sanofi's Soliqua, are now required to include information about the potential risk of NAION on their warning labels.

NAION is characterized by a sudden reduction of blood flow to the optic nerve, resulting in acute, painless decreased vision in one eye, and may lead to permanent vision loss. Common risk factors include diabetes, smoking, hypertension, and hypercholesterolemia. The FDA's decision stems from a 2024 study published in JAMA Ophthalmology, which found an increased risk of NAION among patients using GLP-1 medications.

The FDA reviewed 126 clinical trials involving over 134,200 patients and identified 15 probable NAION cases, with a 6.4 cases per 100,000 person-years incidence rate among GLP-1 patients, compared to 3.8 cases among those on placebo or other glucose-lowering medications. The FDA emphasized that there is currently no treatment to reverse vision loss from NAION.

Novo Nordisk responded to the FDA announcement, stating that they still believe the data does not establish a cause-and-effect relationship and remain confident in the benefit-risk profile of their GLP-1 medicines.