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FDA Warns GLP-1 Drugs May Cause Rare Eye Condition
· Confirmed
In Short: 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.
FDA orders new warning on GLP-1s over rare eye condition. NBC News
The Food and Drug Administration (FDA) has issued a warning that GLP-1 drugs, commonly used to treat obesity and diabetes, 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.
In a meta-analysis of 126 clinical trials involving over 134,253 participants, the FDA identified 15 probable NAION events, with 10 occurring in patients treated with GLP-1 medications and five in those receiving placebo. The risk was estimated to be approximately 6.4 NAION cases per 100,000 person-years for GLP-1 users, compared to 3.8 per 100,000 person-years for those treated with placebo or other glucose-lowering medications.
The FDA's decision to require warning labels on GLP-1 drugs was prompted by a 2024 study published in JAMA Ophthalmology, which found that patients prescribed semaglutide were about four times more likely to develop NAION than those not prescribed the drug. The agency also conducted a separate retrospective cohort study comparing people with type 2 diabetes who received either a GLP-1, an SGLT2 inhibitor, or a DPP-4 inhibitor between 2019 and 2024.
The FDA emphasized that NAION occurs when the optic nerve suddenly loses its blood supply, leading to vision loss, sometimes described as a 'stroke of the eye.' The condition is rare but appears to be increased in people using all currently marketed GLP-1-based medications.
The warning will be added to the Warnings and Precautions section of the drug labels 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 FDA advises that patients experiencing symptoms of NAION should discuss with their doctor whether to continue taking their GLP-1 RA medication or to stop it. Risk factors for NAION may include smoking, diabetes, high blood pressure, sleep apnea, anemia, and kidney disease.
The 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.
In making its decision, the FDA carried out a meta-analysis of GLP-1 development programs and found a higher rate of NAION in patients treated with GLP-1 RAs.
There were no NAION cases in patients who received other, non-GLP-1 RA glucose-lowering medication, highlighting the specific risk associated with GLP-1 drugs.
The FDA's warning is a significant step in ensuring patient safety and informing healthcare providers and patients about the potential risks associated with GLP-1 drugs.
The FDA's decision to require warning labels on GLP-1 drugs underscores the importance of ongoing monitoring and evaluation of drug safety, especially for medications used widely in the treatment of chronic conditions like obesity and diabetes.
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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