zerohedge.comFactualityFactuality is a Premium featureRightRightBased on the outlet's overall lean; article framing check pending

"Consider Discontinuing": FDA Slaps "Eye Stroke" Warning On All GLP-1 Weight-Loss Drugs The FDA is requiring the makers of every GLP-1 drug on the U.S. market, Ozempic, Wegovy, Mounjaro and Zepbound among them, to warn of a potential increased risk of an "eye stroke" that can cause sudden, permanent vision loss in one eye. The condition is non-arteritic anterior ischemic optic neuropathy, or NAION. The agency's Nov. 9 drug safety communication puts the language in the Warnings and Precautions section of labels for a dozen products, from Byetta, approved in 2005, to Lilly's newly approved Foundayo. FDA said it "concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs" and told clinicians to consider discontinuing the drug in patients who develop NAION, unless the benefits clearly outweigh the risk. FDA's review of 126 randomized trials covering 134,253 patients found 15 probable NAION events: 10 among patients on GLP-1 drugs, 5 on placebo and none on other glucose-lowering drugs. That works out to 6.4 cases per 100,000 person-years on GLP-1 drugs against 3.8 for comparators. The agency puts the background rate for adults over 50 at 2.3 to 10.2 cases per 100,000 people a year. A separate FDA Sentinel cohort of type 2 diabetes patients from 2019 to 2024 saw 26 to 32 cases per 100,000 person-years. Compared with SGLT-2 inhibitors, the GLP-1 increase was not statistically significant (hazard ratio 1.19, 95% confidence interval 0.91 to 1.54). Compared with DPP-4 inhibitors, it was: a hazard ratio of 1.43 (1.02 to 2.01). The agency said published observational studies that it judged methodologically rigorous consistently found higher NAION risk on GLP-1 drugs than on DPP-4 or SGLT-2 inhibitors. Its review of animal data identified no mechanism linking the drugs to the condition, and it called adverse event reports hard to interpret because NAION's risk factors overlap with conditions common among GLP-1 users. FDA noted…

2 days ago · zerohedge.com · You are reading this one