LOS ANGELES, Nov. 9 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Monday required manufacturers of all glucagon-like peptide-1 (GLP-1) receptor agonist medications to update their safety labeling to include information about a potential increased risk of a rare but serious eye condition that can cause permanent vision loss.
In a drug safety communication issued Monday, the FDA alerted patients and health care providers to a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with the use of GLP-1 receptor agonist medications.
NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss, the FDA said.
The requirement applies to all GLP-1 receptor agonist medications, including semaglutide products such as Ozempic and Wegovy, as well as tirzepatide products Mounjaro and Zepbound.
The FDA required manufacturers to add information about the potential increased risk of NAION to the Warnings and Precautions section of their product labeling.
An FDA analysis of 126 randomized, controlled clinical trials found 6.4 NAION cases per 100,000 person-years among patients treated with GLP-1 receptor agonists, compared to 3.8 NAION cases per 100,000 person-years in patients receiving a placebo or other glucose-lowering medications.
The FDA said it reviewed clinical trial data, animal data, post-marketing data, including observational studies and case reports, before concluding that there is a potential increased risk of rare NAION events in patients taking GLP-1 receptor agonists.
