FDA requires vision-loss warnings on GLP-1 drugs such as Wegovy and Zepbound
The U.S. Food and Drug Administration said on Monday that makers of all GLP-1 medicines must add new safety warnings after a review of clinical trials, real-world patient data and published studies found evidence of a possible higher risk of nonarteritic anterior ischemic optic neuropathy (NAION). The rare condition is caused by reduced blood flow to the front of the optic nerve and can bring sudden vision loss, including permanent loss; the underlying cause is not fully understood, and the agency has not established a causal link with the drugs.
An analysis of 126 trials involving more than 134,000 patients found 6.4 NAION cases per 100,000 patient-years among GLP-1 users, versus 3.8 among people on other treatments or placebos. Several observational studies also pointed to higher risk. Cases have been reported for every currently marketed GLP-1 product. CNBC sought comment from Novo Nordisk, which makes Ozempic and Wegovy, and from Eli Lilly, which makes Mounjaro, Zepbound and Foundayo.
Citi analysts said the class-wide labeling change is likely to draw attention but should have limited effect on uptake: concern among patients and investors may rise briefly, yet the rarity of NAION and the drugs’ benefits for weight, blood sugar, cardiovascular and kidney disease and sleep apnea should keep the benefit-risk balance favorable and limit shifts in prescribing. Many GLP-1 medicines already carry the FDA’s strongest boxed warning over a possible risk of thyroid tumors. Semaglutide, the active ingredient in Wegovy and Ozempic, and tirzepatide, the active ingredient in Mounjaro, cause thyroid C-cell tumors in rodents; it is unknown whether they cause those tumors, including a rare thyroid cancer, in people.
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