America's Food and Drug Administration (FDA) is warning that popular obesity drugs, including Ozempic, Wegovy, Zepbound, and Mounjaro, may carry a "potential increased risk" of a rare eye condition that can lead to permanent vision loss. For those unaware, Mounjaro, Ozempic and Wegovy are all part of a buzzy class of drugs known as GLP-1 agonists, which are seen as potential game-changers for patients struggling with obesity and diabetes. In a recent drug safety communication, the FDA said that it will now require makers of GLP-1 receptor agonist drugs to add a warning about that risk on their drug labels. As per the advisory, "The US 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. NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss."

What is the condition FDA has warned about

It’s unknown how GLP-1 drugs may cause NAION. The condition is rare overall, occurring in somewhere between two and 10 people in 100,000 in the general population, according to the American Academy of Ophthalmology. These small numbers have reportedly made it more difficult to determine with certainty if there is a connection. Further complicating the potential link is the fact that the risk factors for developing NAION are common among patients taking GLP-1 drugs. The risk factors include diabetes, cardiovascular disease, high blood pressure, high cholesterol, metabolic syndrome, and obstructive sleep apnea.

When Elon Musk admitted taking anti-obesity drug

In December 2024, Elon Musk showed off a trimmer figure in a holiday social media post while revealing that he has been taking an anti-obesity drug to shed weight. Tesla CEO posted a photo of himself on Twitter on Christmas Day dressed up in a Santa costume, captioning the picture, "Ozempic Santa." He added, "Technically, Mounjaro, but that doesn't have the same ring to it." A few days earlier in another post on these medicines, Musk wrote, "Nothing would do more to improve the health, lifespan and quality of life for Americans than making GLP inhibitors super low cost to the public. Nothing else is even close."

What FDA data says

In July 2024, Hathaway et al. published an article titled “Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide.”[1] Although FDA identified several limitations of this study, the agency determined that further assessment of the potential increased risk for NAION was warranted. Therefore, FDA undertook a comprehensive evaluation of clinical trial data, animal data, and postmarketing data, including observational studies and case reports. FDA conducted a detailed review of reports of NAION in patients treated with GLP-1 RAs that were received through the FDA Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). These reports were challenging to interpret because the risk factors for NAION often overlap with conditions common in patients treated with GLP-1 RAs. Therefore, FDA evaluated other data sources, described below, to further assess for a potential relationship between GLP-1 RA use and NAION. FDA review of the available animal data did not identify a mechanism for how GLP-1 RA use could increase the potential risk of NAION. FDA performed a meta-analysis of clinical trials across GLP-1 RA development programs because of the small number or absence of cases of NAION observed in individual trials. The primary objective of the meta-analysis was to assess the incidence of NAION events in patients treated with GLP-1 RAs compared to the incidence in patients treated with a comparator (a placebo or a non-GLP-1 RA glucose-lowering medication). There were 126 such trials for GLP-1 RAs included in the meta-analysis, including a total of 134,253 patients (78,217 GLP-1 RA users and 56,036 patients receiving a comparator) with 288,879 PY of exposure (156,947 PY for the GLP-1 RA users and 131,932 PY for the patients receiving a comparator). We identified 15 probable NAION events, 10 in patients treated with GLP-1 RAs, 5 in patients receiving placebo, and none in patients who received other non-GLP-1 RA glucose-lowering medication. Overall, the results showed a NAION incidence rate of 6.4 events per 100,000 PY in patients treated with GLP-1 RAs compared to 3.8 events per 100,000 PY in comparator-treated patients.

End of Article

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