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The makers of blockbuster weight-loss drugs such as Ozempic and Zepbound will be required to include warnings about a rare eye condition that can cause permanent vision loss.
Taking any GLP-1 medication carries an increased risk of a rare condition known as “non-arteritic anterior ischemic optic neuropathy,” or “NAION,” the U.S. Food and Drug Administration said Monday.
NAION can result in painless but decreased vision in one eye, caused by reduced blood flow to part of the optic nerve. It’s sometimes referred to as an “eye stroke.”
There is no treatment for the condition, though the first cases were reported at the beginning of the 19th century.
“NAION cases have been reported for all currently marketed GLP-1 RA products,” the FDA said. “FDA concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs.”
The decision follows a comprehensive review of NAION in patients who were taking the drugs, incorporating reports received through the FDA’s Adverse Event Monitoring System and studies involving more than 134,000 patients.
The FDA analysis found about six cases of NAION per 100,000 people taking GLP-1 drugs every year.
