FDA requires GLP-1 labels to warn of a rare vision-loss risk

The FDA said on November 9 that it is requiring makers of all GLP-1 receptor agonist drugs to add a warning about a potential increased risk of a rare eye condition. The condition, non-arteritic anterior ischemic optic neuropathy, can cause sudden, painless vision loss in one eye, including permanent loss.

The new text goes in the Warnings and Precautions section. The drugs are used to treat type 2 diabetes and to reduce body weight. The agency's approved list includes Ozempic, Wegovy, Mounjaro, and Zepbound.

The FDA reviewed 126 randomized trials with 134,253 patients. It found 15 probable cases: 10 in people taking a GLP-1 drug and 5 in people on a placebo. The rate was 6.4 cases per 100,000 person-years for the GLP-1 drugs, against 3.8 for the comparison group. In adults older than 50, the agency said the general-population rate is 2.3 to 10.2 cases per 100,000 people a year.

A separate review of insurance records did not find a statistically significant increase against SGLT-2 inhibitors. The hazard ratio there was 1.19, and the confidence interval crossed 1. It did find a higher risk against DPP-4 inhibitors, with a hazard ratio of 1.43 and a 95 percent confidence interval of 1.02 to 2.01. The agency said animal data did not show how the drugs would raise the risk. It still concluded there is a potential increased risk.

The FDA said patients who notice sudden vision loss, missing patches of sight, or distorted colors should contact a health care professional right away. It said a patient who has already had the condition should talk with a professional about whether to stop.