FDA requires GLP-1 drugs to warn of potential risk of rare eye condition
The condition, NAION, can cause permanent vision loss in one eye, the FDA says, while Novo Nordisk says data do not establish cause and effect.
The US Food and Drug Administration announced on Monday, Nov. 9, that makers of GLP-1 drugs must add a warning about a rare eye condition to their labels. The condition is non-arteritic anterior ischemic optic neuropathy, or NAION, sometimes called an "eye stroke." It comes from reduced blood flow to the optic nerve and can cause painless vision loss in one eye.
The loss can be permanent, and there is no proven treatment. According to the agency's findings, rare NAION events may potentially become more likely with these drugs. Cases have been reported with all currently marketed GLP-1 products, including Ozempic, Wegovy, Mounjaro and Zepbound.
The agency began its review after a 2024 observational study linked Ozempic and Wegovy to the condition. In animal data, the did not identify how the drugs could raise the risk. Novo Nordisk says the data do not establish cause and effect.
Eli Lilly says it is evaluating the update, which it notes does not reference findings specific to its medicines. The FDA tells patients to contact a health professional right away if they have symptoms such as sudden vision loss in one eye.
- more than 134,000 patientscovered by studies in the FDA's reviewThe Independent
- 6.4 cases of probable NAION per 100,000 person-yearsrate among GLP-1 users, per the FDA as reported by the Epoch TimesThe Epoch Times
- 3.8 cases per 100,000 person-yearsrate in the placebo or non-GLP-1 comparison groupsThe Epoch Times
- Roughly 28 million Americanstaking GLP-1 drugs, by a July Gallup pollThe Independent
- 3.2%rise in Lilly's shares on MondayThe Seattle Times
Three sides of the story
16 news outlets reported this
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Liberal6 outlets
A mandatory warning backed by FDA review figures
The Independent leads with the requirement itself: makers of drugs such as Ozempic and Zepbound must warn about a rare condition "that can cause permanent vision loss." It quotes the FDA saying NAION cases "have been reported for all currently marketed GLP-1 RA products," and gives figures: studies of more than 134,000 patients, and about six cases per 100,000 people a year on the drugs against about four in comparison groups. It adds a May American Academy of Ophthalmology review and a Gallup estimate of roughly 28 million Americans on GLP-1s.
Novo Nordisk's Liz Skrbkova says the data "do not establish a cause-and-effect relationship," and an Eli Lilly spokesperson says the company is evaluating the update. The Boston Globe runs a STAT report saying the FDA warned of a potential risk of a rare but serious eye condition. It notes the review began after a 2024 observational study and that the agency's review of animal data did not identify a mechanism.
Center5 outlets
New FDA label requirement, symptoms and drugmakers' responses
UPI opens with the FDA's announcement of new safety labeling for GLP-1 RA drugs such as Zepbound and Wegovy. It then explains how the drugs work, lists approved brand and generic names, and details symptoms and risk factors including smoking, diabetes and sleep apnea. The Seattle Times, running a Bloomberg report, leads with Novo Nordisk and Eli Lilly having to add warning labels about a potential rare side effect.
It recalls a 2024 Harvard University study and four patients who won compensation in Denmark. It also reports Lilly shares up 3.2% and Novo up 1.2% on Monday. Liz Skrbkova of Novo says her firm is sure of the benefit-risk profile of its medications, while a Lilly spokesperson observes the update lists no cases tied to Lilly's medicines.
NewsNation's headline says the FDA requires safety label changes over the risk of an eye condition, and it notes NAION is often called an "eye stroke."
Conservative5 outlets
A rare risk, and the limits of evidence
Townhall leads with the FDA requiring the warning, then stresses "NAION is extremely rare," citing 10 probable events in trials of 134,000 people, a rate of 6.4 per 100,000 users per year. It notes the move follows reports of dozens of lawsuits and says cases are hard to tie definitively to GLP-1s because patients often have diabetes and obesity. The New York Post's headline calls NAION an "incurable blindness condition."
It cites a 2024 study in which diabetes patients on semaglutide were four times more likely to develop it, notes limitations the FDA identified, and relays the agency's advice to consider stopping the drug in patients who develop NAION unless benefits clearly outweigh the risk. The Epoch Times quotes a Lilly spokesperson and says Novo did not return a request for comment. It reports 6.4 versus 3.8 cases per 100,000 person-years, with a statistically significant increase against DPP-4 inhibitors but none against SGLT-2 inhibitors.
- Liberal outlets did not mentionFour patients in Denmark won compensation after developing NAION Reported by The Seattle Times, The Epoch Times
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The FDA says patients on GLP-1 drugs should contact a health professional right away if they notice symptoms such as sudden, painless vision loss in one eye. The FDA is urging providers to tell patients to report such changes, according to the New York Post. Roughly 28 million Americans take these drugs, according to a July Gallup poll cited by The Independent.
All sources: 18 articles from 16 outlets
Liberal (7)
- La Opinión: FDA advierte sobre pérdida de visión posiblemente causada por medicamentos GLP-1
- The Boston Globe: FDA warns GLP-1 drugs carry potential risk of rare eye condition
- The Daily Beast: Women Flock to New Surgery for Annoying Ozempic Side Effect
- The Guardian: FDA warns of rare eye condition causing blindness from GLP-1 weight loss medications
- The Independent: Weight loss drugs linked to new rare side effect as new warning labels required
- The Independent: US is requiring weight-loss drug makers to warn about possible loss of eyesight
- Vox: Why are fewer Black Americans getting GLP-1s?
Center (5)
- BBC News: Makers of GLP-1 drugs ordered to add warnings about rare eye condition that can lead to blindness
- Forbes: Novo CEO Doustdar On What’s New For Ozempic, Wegovy, GLP-1s, Obesity
- NewsNation: FDA requires safety label changes for GLP-1s over risk for eye condition
- The Seattle Times: FDA adds warning label to obesity drugs for eye condition
- UPI: FDA announces new safety labeling for GLP-1 RA medications
Conservative (6)
- Just the News: Weight loss drugs, such as Ozempic, to carry FDA warning about rare vision-loss side effects
- Just the News: Weight loss drugs, such as Ozempic, to carry FDA warning about rare vision-loss side effects
- New York Post: GLP-1 drugs must have new warning label over incurable blindness condition, says FDA
- The Epoch Times: FDA Mandates New Eye Risk Warning on GLP-1 Drugs
- The Washington Times: Doctors shun 'miracle drug' label for GLP-1s amid emerging health claims about weight-loss drugs
- Townhall: FDA Now Requiring GLP-1 Makers to Warn About Rare but Severe Eye Condition
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