FDA orders new warning on GLP-1 drugs over potential risk of blindness
The makers of GLP-1 weight loss drugs such as Ozempic, Wegovy and Mounjaro must add a warning label about a possible link to permanent vision loss , the US Food and Drug Administration has said. The regulator said that it based the decision on research that linked a rare eye condition, called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause blindness, and Glucagon-like…
The US Food and Drug Administration (FDA) has mandated that makers of GLP-1 weight loss drugs, such as Ozempic, Wegovy, and Mounjaro, incorporate a warning label concerning potential vision loss. The decision was informed by research suggesting a link between these medications and a rare eye condition, non-arteritic anterior ischemic optic neuropathy (NAION), which can lead to permanent blindness.
An FDA bulletin issued last week stated that the decision was based on clinical trial data, observational studies, and a 2024 article examining the potential connection between NAION and GLP-1 drugs.
NAION, a rare condition, can cause acute, painless vision loss in one eye and may result in permanent vision impairment. Individuals with a history of NAION are at an increased risk. The FDA advised healthcare providers to inform patients to discontinue using GLP-1 medications if signs of NAION develop, unless the benefits of treatment are clear. The warning labels will now detail the link between GLP-1 receptor agonist (GLP-1 RA) medications and the heightened risk of NAION.
According to an analysis of 126 randomized controlled trials across multiple GLP-1 RAs, there were 6.4 NAION cases per 100,000 person-years in patients treated with these medications, compared to 3.8 cases per 100,000 person-years for those on a placebo or non-GLP-1 RA glucose-lowering treatment. Novo Nordisk, which manufactures Ozempic and Wegovy, stated that available research does not conclusively prove that GLP-1 medications cause NAION.
Despite this, the FDA insists on the inclusion of the warning and precaution information in the drug labeling.
Written by urgent.news from The National Business's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
