FDA requires vision loss warning on GLP-1 drug labels
Agency cites rare risk of optic nerve condition known as NAION
WASHINGTON (WBAY) - The FDA is requiring drugmakers to include a warning label on some GLP-1 medications for the risk of a rare condition that can decrease vision or cause permanent vision loss in one eye.
The condition is called non-arteritic anterior ischemic optic neuropathy, or NAION. It also is known as an optic nerve stroke.
What the FDA says
The FDA said a study in 2024, published in the journal JAMA Opthamology, highlighted the potential risk associated with GLP-1 RA medications.
Nearly all GLP-1 drugs prescribed for diabetes and weight loss are GLP-1 RAs. They include Ozempic, Wegovy, Trulicity and Mounjaro.
The agency said it performed additional analyses of a wide range of data before deciding to require the addition to the drugs’ labels.
The FDA said NAION cases have been reported for all currently marketed GLP-1 RAs.
Signs to look out for
Signs of NAION include:
- Sudden, painless vision loss in one eye that may be noticed upon waking
- Blurred or missing portions of vision, such as blind spots or tunnel vision
- Distorted colors
- Blurry or hazy spots
People who have any of these symptoms should contact a doctor right away.
Possible causes and treatment
The Cleveland Clinic said experts are not totally sure why NAION happens, but it could be due to events that disrupt blood flow to the optic nerve.
Those include factors such as high blood pressure, sleep apnea and smoking or vaping.
The Cleveland Clinic said there is no confirmed effective treatment. The main approach is to manage symptoms and minimize underlying causes.
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