Ozempic, Wegovy, and Rybelsus Will Now Warn of Rare Vision Loss Risk in Europe

The European Medicines Agency has just made it official. Semaglutide, the active ingredient in Ozempic, Wegovy, and Rybelsus, can in very rare cases cause a serious eye condition known as NAION, which stands for non-arteritic anterior ischemic optic neuropathy. It is a mouthful, but here is what matters: NAION can cause sudden and sometimes permanent vision loss.

This decision came after the EMA’s Pharmacovigilance Risk Assessment Committee spent months digging through studies, post-marketing surveillance, and other data. Their conclusion is that about 1 in 10,000 people on semaglutide may experience NAION, with slightly higher risk for those with type 2 diabetes.

The warning label for semaglutide in the EU will now reflect this risk. Patients are being told to stop taking the drug and contact their doctor immediately if they experience sudden vision loss or a rapid decline in eye sight

This EU review was triggered earlier this year after JAMA published research showing patients on semaglutide were more than eight times more likely to develop NAION than those on other medications. Denmark’s own regulator flagged additional data suggesting that semaglutide may more than double the risk of this condition, which prompted the EMA to take a closer look.

To be clear, this is still considered a rare event. But it is one to be aware of, especially if you are on one of these drugs and notice any change in your vision.

At this point, the U.S. FDA has not yet issued any new guidance on this matter. We will be watching closely to see if an FDA update follows.