GLP-1 Drugs Receive New Warning Labels Over Rare Blindness Risk

The U.S. Food and Drug Administration (FDA) on Monday ordered the GLP-1 drugmakers to add a warning label about a rare eye condition that can cause sudden blindness. The condition is called non-arteritic anterior ischemic optic neuropathy, or NAION. Often described informally as an "eye stroke," it happens when blood flow to the front part of the optic nerve gets suddenly reduced or blocked.

The new alert aims to warn patients and doctors about a rare eye condition that can lead to sudden, permanent vision loss. This issue causes painless vision loss in one eye, which people often first notice when they wake up.

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Other warning signs include blurry spots, missing parts of vision, tunnel vision, or trouble seeing colours clearly. Currently, doctors say the condition is permanent and has no proven medical treatment.

"The U.S. Food and Drug Administration is informing patients and health care providers of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications," the FDA announced on November 9.

"NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss."

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Why the decision was made

The health regulators in the US announced it after following multiple reviews of clinical data, observational studies, and patient reports.

While the absolute risk of developing NAION remains very small, researchers noted that even a slight increase in risk can impact a large number of people given how widely these medications are prescribed.

"We don't want patients to really get overly concerned and anxious and to stop these medications," Dr Manjot Gill, an ophthalmologist at Northwestern Medicine in Chicago, said, as quoted by NBC News. He called the FDA's mandate appropriate.

"It's fine to issue this warning more so for public awareness so that patients, should they experience any kind of change in vision, that they do actually go and seek the care of an eye provider."

The order applies to all GLP-1s, including Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro and Zepbound.

According to the media outlet, major drugmakers responded to the announcement, with representatives noting they are reviewing the updated guidelines.