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Reporter Madeline Halpert
The U.S. Food and Drug Administration (FDA) on Thursday directed manufacturers of GLP-1 receptor agonists used to treat diabetes and obesity to add warnings about rare eye diseases that can cause sudden blindness.
The manufacturers of Manjaro, Zepbound (both generic names: tirzepatide), Ugobi, and Ozempic (both generic names: semaglutide) must now warn users of these drugs about non-arteritic anterior ischemic optic neuropathy (NAION). The disease occurs when the blood vessels that supply blood to the optic nerve become clogged, cutting off the oxygen supply.
According to the FDA, NAION can cause rapid and painless vision loss in one eye. In some cases, the vision loss may become permanent.
"The additional risk appears to be small and the fact that these drugs cause NAION has not been established," the American Academy of Ophthalmology said in a statement to the BBC.
"GLP-1 receptor agonists offer important benefits for patients with diabetes, obesity, and heart disease, which is why our message to patients is simple: Do not stop taking them without consulting your doctor. Also, if you experience sudden, painless vision loss in one eye, seek immediate medical attention from an ophthalmologist."
No treatment has been found to reverse vision loss caused by NAION. According to the American Academy of Ophthalmology, NAION is the most common cause of acute optic nerve damage in people over 50.
The FDA said that after a detailed investigation into the development of NAION in patients using GLP-1 products and a review of other studies, it concluded that there is an "increased risk of rare cases of NAION" in people using GLP-1 products.
Danish pharmaceutical giant Novo Nordisk, which makes Ugobi, one of the most popular weight-loss drugs, said in a statement that it believes the data "does not establish a causal relationship."
"We recognize that NAION can have a serious impact on patients and their families. Patient safety is our top priority and we continually monitor the safety of our medicines."
The FDA explained that review of some studies was difficult because people taking GLP-1 receptor agonists to treat obesity or type 2 diabetes may already have risk factors for NAION independent of the drug. It is also unclear why people taking GLP-1 receptor agonists are at higher risk of developing NAION.
These drugs already carry warning labels for several other conditions, including pancreatitis and gallbladder disease. The most common symptoms of semaglutide, the main ingredient in many GLP-1 receptor agonists, include nausea, vomiting, and abdominal pain.
Last year, the European Medicines Agency (EMA)'s safety arm said that up to 1 in 10,000 people taking semaglutide could be affected by NAION.
A study published in 2024 that analyzed 17,000 patients found that patients taking semaglutide were four times more likely to be diagnosed with NAION than those not taking it.
However, Joseph Rizzo, a professor of ophthalmology at Harvard Medical School and one of the study's authors, said the results were "important but preliminary" and that additional research was needed to examine the association between these drugs and eye disease in a more diverse population.
(English article Makers of GLP-1 drugs ordered to add warnings about rare eye condition that can lead to blindness)
