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FDA Requires GLP-1 Drugs to Carry Warning About Rare Eye Condition
· Confirmed
In Short: The FDA has mandated that all GLP-1 drugs include a warning about a potential increased risk of nonarteritic anterior ischemic optic neuropathy (NAION), a rare eye condition.
FDA orders warning on popular GLP-1 weight loss drugs. NBC News
The Food and Drug Administration (FDA) has issued a warning that GLP-1 drugs may carry a potential risk of nonarteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can lead to sudden and often permanent vision loss.
According to the FDA, NAION cases have been reported for all currently marketed GLP-1 receptor agonist products, including Ozempic, Wegovy, Mounjaro, Zepbound, and other pill-based and injectable drugs.
In a meta-analysis of 126 clinical trials, including a total of 134,253 participants, the FDA identified 15 probable NAION events. Of these, 10 were in GLP-1-treated individuals, five in those receiving placebo, and none in those receiving other glucose-lowering drugs.
The risk was estimated to be approximately 6.4 NAION cases per 100,000 person-years with GLP-1s, compared to 3.8 per 100,000 person-years for those treated with placebo or other glucose-lowering medications.
The FDA will now require GLP-1 medications to carry labeling information about the potential increased risk for NAION. This information will be added to the Warnings and Precautions section of the drug labels.
The FDA's decision follows a 2024 study published in JAMA Ophthalmology that found diabetes patients prescribed semaglutide were four times as likely to develop NAION as those not prescribed the drug.
The FDA advises that if patients think they may have experienced NAION, they should talk with their doctor about whether to continue taking their GLP-1 RA medication or to stop it.
What this adds
The FDA's warning is a new requirement for all GLP-1 drugs, including Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound, as well as several older GLP-1 diabetes medications.
The condition, NAION, leads to sudden and often permanent vision loss due to decreased blood flow to the optic nerve.
The FDA's warning adds urgency to the ongoing discussions about the safety and efficacy of GLP-1 drugs, particularly in light of the potential increased risk of NAION.
Background
The FDA has required drugmakers to add warnings about a potential increased risk of NAION, a rare eye condition, to the labels of all GLP-1 drugs.
What's confirmed
- The FDA said “there is a potential increased risk of rare NAION” in people taking GLP-1 drugs.
- The Food and Drug Administration said the risk will be added to the labeling of all GLP-1 drugs, the blockbuster medications used to treat obesity, diabetes and several other medical conditions.
- The eye condition, called nonarteritic anterior ischemic optic neuropathy, or NAION, leads to sudden and often permanent vision loss.
- According to the Food and Drug Administration, NAION cases have been reported for all currently marketed GLP-1 receptor agonist products, including Ozempic, Wegovy, Mounjaro, Zepbound and other pill-based and injectable drugs.
- The problem, which has been reported with all GLP-1 drugs, is caused by decreased blood flow to the optic nerve, although the underlying cause isn’t understood, the FDA said.
- "FDA's drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines." An FDA analysis of more than 125 clinical trials found that the problem occurred in roughly 6 of every 100,000 patients who took a GLP-1 for at least one year.
What's still developing
- Test your knowledge with our new weekday mini crossword The Food and Drug Administration on Monday warned that GLP-1 drugs carry a potential risk for a rare but serious eye condition and required pharma companies to inform patients and doctors of the risk.
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