The US Food and Drug Administration said on Monday, November 9, that makers of all approved GLP-1 medicines must add a warning about a potential increased risk of a rare eye disorder that can cause permanent vision loss. The decision covers widely used diabetes and weight-loss drugs, including Ozempic, Wegovy, Mounjaro and Zepbound. The agency placed the information in the warnings and precautions section of their labels.
The condition, non-arteritic anterior ischemic optic neuropathy, or NAION, involves reduced blood flow to the front of the optic nerve. It can cause sudden, painless loss of sight in one eye. The FDA said its underlying cause is not fully understood and that people with diabetes, high blood pressure, sleep apnea or other risk factors may already be more vulnerable.
In an analysis of 126 randomized trials, the FDA found 6.4 probable NAION cases per 100,000 person-years of exposure among GLP-1 users, compared with 3.8 among people given a placebo or another type of glucose-lowering drug. The review covered 134,253 participants and identified 15 probable cases in total. Those small numbers mean the condition remains rare, even as the agency requires a class-wide warning.
The agency also reviewed adverse-event reports and observational research. Its own study of adults with type 2 diabetes found a higher risk compared with one category of diabetes medicine, but no statistically significant increase compared with another. The FDA said overlapping medical risk factors make individual reports difficult to interpret, and animal data did not reveal a mechanism linking the medicines to the eye injury.
The medicines mimic a hormone that helps regulate blood sugar and appetite, and some have additional approved uses for heart, kidney and other conditions. The new US labeling requirement therefore affects a broad group of patients and prescribers. Reuters and the Associated Press reported the decision after the FDA issued its safety communication; the agency described the finding as a potential risk, not proof that every vision-loss event was caused by treatment.
Patients who notice sudden painless loss of vision, blind spots, blurred sight or distorted colors should contact a health professional immediately, the FDA advised. Clinicians should arrange prompt eye assessment if NAION is suspected and weigh whether treatment should continue. The agency said people who have already had NAION should discuss that decision with their clinician, while manufacturers update the required labels.
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