If you’re one of the millions of Americans currently taking a GLP-1 drug like semaglutide (Ozempic and Wegovy), listen up: The Food and Drug Administration is officially warning users about a rare but serious vision-robbing condition linked to the products.

On Monday, the FDA stated that semaglutide and other GLP-1s on the market carry a potential increased risk of non-arteritic anterior ischemic optic neuropathy, or NAION. The agency is now mandating that all GLP-1 makers add a warning disclosing this risk to their labeling. Though both doctors and patients should be aware of the possible side effect, NAION appears to be a rare complication of GLP-1 use, the FDA says.

NAION is caused by decreased or stopped blood flow to the optic nerve, which can then lead to sudden and painless vision loss in the eye. Though people may recover some vision, the structural damage caused by an episode of NAION is typically permanent, and people who have NAION in one eye are more likely to later develop it in the other.

While the exact causes of NAION are unclear, people over the age of 50 and with high blood pressure seem to be more susceptible to it. In recent years, eye doctors have also started to notice a possible increase in NAION cases among people taking a GLP-1. Health officials in Europe eventually began a formal investigation into this suspected connection, which the FDA did as well.

The FDA analyzed past observational studies, clinical trial data, and post-market safety data, all of which pointed to a consistent increased risk of NAION associated with GLP-1 use.

Source link