FDA requires vision loss warnings on GLP-1 diabetes and weight loss drugs

The US Food and Drug Administration (FDA) will require new warnings about a rare but serious eye condition causing sudden and permanent vision loss on labels of popular diabetes and weight loss drugs, according to ktsmradio.iheart.com and newstalk1090.iheart.com.

These drugs, known as GLP-1 receptor agonists, include Ozempic, Wegovy, Mounjaro, and Zepbound. The FDA's decision follows a review of clinical trials, animal studies, and post-marketing reports linking these medications to non-arteritic anterior ischemic optic neuropathy (NAION), a condition that affects blood flow to the optic nerve and can result in painless, acute vision loss.

The FDA noted that risk factors for NAION overlap with conditions common among GLP-1 users such as type 2 diabetes, high blood pressure, and sleep apnea. A large study cited by CNN found the risk of developing NAION more than doubled after two years of treatment with a GLP-1 drug compared to other diabetes medications.

The new warning will be added to the "warnings and precautions" section of drug labels for Novo Nordisk's Ozempic and Wegovy, Eli Lilly's Mounjaro and Zepbound, and several older GLP-1 medications. The FDA did not identify a clear mechanism for how these drugs might increase NAION risk but emphasized monitoring for sudden vision changes.

These drugs already carry warnings for pancreatitis, gallbladder issues, kidney injury, and a black box alert for possible thyroid tumors. The FDA's new labeling requirement is effective immediately, and patients taking GLP-1 drugs are urged to watch for sudden vision changes and consult healthcare providers if symptoms occur.