The FDA is adding a new warning label onto GLP-1 drugs like Ozempic and Zepbound for a rare side effect with serious risk.
All GLP-1 drug makers will now be required to include new safety warnings informing patients that the medications could increase risk of sudden vision loss from a condition known as nonarteritic anterior ischemic optic neuropathy (NAION). The condition, which is not common, can lead to sudden decreased vision in one eye and even permanent vision loss. The condition’s causes aren’t fully understood, but it happens when blood flow to the front of the optic nerve decreases.
“NAION cases have been reported for all currently marketed GLP-1 [receptor agonist] products,” the FDA wrote in its new guidance. The new warning will appear on all GLP-1 drugs, including Ozempic, Wegovy, Zepbound, Mounjaro, older GLP-1 agonists, and Foundayo, Eli Lilly’s new GLP-1 pill. The information will appear in the “warnings and precautions” section of prescription labels for the popular drugs.
Ozempic and other GLP-1 drugs have been hailed as a modern medical miracle, treating everything from diabetes and obesity to kidney disease to addiction. But even as the drugs become much more widely prescribed, researchers continue to learn about what they can do and how they work. That could mean more warning labels in the future.
The FDA began exploring the connection between GLP-1 drugs and vision loss after a 2024 study found that use of semaglutide in diabetes patients was associated with NAION. The study’s observational design means it can’t prove a causal link between semaglutide-based GLP-1 drugs and vision loss from the condition, but the research was enough to prompt the agency to launch “comprehensive evaluation” of research on the topic, including clinical trial data, animal data, case reports, and other observational studies.
Source link







