The FDA is requiring makers of GLP-1 receptor agonist medicines to add a warning about a possible increased risk of NAION, a rare eye condition that can cause sudden, painless vision loss in one eye and sometimes permanent damage.
The requirement covers medicines including Ozempic and Wegovy (semaglutide), Mounjaro and Zepbound (tirzepatide), as well as other GLP-1 drugs.
The FDA cited reports and its review of studies and clinical-trial data. The evidence suggests a possible association; it does not establish that the medicines cause NAION.
The FDA says patients should seek medical attention promptly for sudden vision loss or other new visual changes. People taking these medicines should discuss concerns with their healthcare provider rather than stopping treatment on their own.
The agency advises clinicians to refer suspected cases for eye evaluation and consider stopping the medicine if NAION is diagnosed, weighing the risks and benefits.
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