The US Food and Drug Administration is requiring updated labeling across the GLP-1 drug class because of a potential increased risk of a rare eye condition that can cause permanent vision loss, the agency announced on Monday, Nov. 9.
The requirement covers medications including Ozempic, Wegovy, Rybelsus, Mounjaro, and Zepbound, according to the FDA’s drug safety communication. Manufacturers must add the information to the Warnings and Precautions section of prescribing information.
The condition, non-arteritic anterior ischemic optic neuropathy, or NAION, involves decreased blood flow to the front of the optic nerve. Its underlying cause is not fully understood.
Symptoms can include sudden, painless vision loss in one eye, sometimes noticed upon waking. Blurred vision, blind spots, tunnel vision, distorted colors, and reduced sharpness can also occur.
Patients experiencing those symptoms should contact a health care professional right away, the FDA says.
The warning follows an agency review of clinical trials, observational studies, animal research, and reports submitted after the drugs reached the market.
An FDA analysis of 126 clinical trials involving 134,253 patients identified 15 probable cases: 10 among GLP-1 users and five among patients receiving a placebo.
The rate was 6.4 cases per 100,000 patient-years among GLP-1 users, compared with 3.8 among patients receiving placebo or another diabetes medication. Patient-years measure the combined time participants were followed.
Those findings point to a rare event, not a certainty that a patient will develop vision problems.
The FDA also noted a complication in assessing reports: Risk factors for NAION overlap with conditions common among people taking these medications. Those factors include diabetes, high blood pressure, sleep apnea, smoking, anemia, and kidney disease.
A separate FDA study found an increased risk compared with one group of diabetes drugs, but no statistically significant increase compared with another.
GLP-1 medications help manage blood sugar or body weight, and some have additional approved benefits.
Patients who have experienced NAION should discuss whether to continue or stop their medication with their health care professional, the FDA advises.
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