FDA requires new safety warnings for GLP-1 drugs
The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers that GLP-1 medications are associated with an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can result in permanent vision loss.
“Symptoms of NAION include sudden, painless vision loss in one eye that patients may notice upon waking; blurred or missing portions of vision (visual defects such as blind spots or tunnel vision); distortion of colors; and reduced central sharpness (e.g., blurry or hazy spots),” the FDA warned in a new drug safety communication. “Patients should contact their healthcare professional right away if they have any of these symptoms.”
This new warning from the FDA comes after the agency reviewed years of data on GLP-1 drugs and the risk of NAION. The agency even performed a retrospective study of its own.
Overall, after looking at more than 100 randomized clinical trials that cover a wide range of GLP-1 medications, the FDA found that there were 6.4 NAION cases per 100,000 person-years in patients treated with GLP-1 drugs and 3.8 NAION cases per 100,000 person-years for patients treated with a placebo or a different glucose-lowering medication. NAION cases were reported for “all currently marketed GLP-1 receptor agonist products.”
Reviewing these data, the FDA concluded that there is “a potential increased risk of rare NAION events in patients taking GLP-1 receptor agonists.” This risk appears to be greater in patients with a history of NAION.
As a result, warnings about this risk are now required to be included on the labeling of these medications going forward.
GLP-1s are one of healthcare’s largest trends
GLP-1 receptor agonists have been one of modern medicine’s biggest trends. Popular versions of these drugs include semaglutide, sold by Novo Nordisk under the brand names Wegovy and Ozempic, and tirzepatide, sold by Eli Lilly and Company under the brand names Zepbound and Mounjaro.
These drugs were originally developed to treat diabetes, but they are now most commonly prescribed for weight loss. In addition, multiple GLP-1 medications have been linked to a wide range of cardiovascular benefits, increasing their popularity among cardiologists. However, as quickly as these drugs were embraced by clinicians, there have been concerns that they could be linked to side effects that have not yet been identified.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.