Several studies have found that people taking GLP-1 medications have an elevated risk for nonarteritic anterior ischemic optic neuropathy, or NAION
The Food and Drug Administration is now requiring all companies that sell GLP-1 drugs like Ozempic and Mounjaro to include information about the possible risk of a rare form of vision loss on the labels.
The U.S. will now require companies that sell GLP-1 medications like Ozempic and Zepbound to include a warning about the possible risk of vision loss.
Several medical studies have detected a link between taking one of the popular medications and nonarteritic anterior ischemic optic neuropathy, or NAION, a rare eye condition that causes vision loss that is often permanent.
The Food and Drug Administration announced Monday that companies need to add information about the possible risk of NAION to all labels for GLP-1 medications. This includes Novo Nordisk (NVO) (DK:NOVO.B), Eli Lilly (LLY) and AstraZeneca (AZN).
Europe already requires that the labels for Novo's Ozempic, Rybelsus and Wegovy list NAION as a "very rare" side effect.
Concerns about NAION bubbled up earlier this fall when reports emerged of patients suing Novo and Lilly, which both sell several GLP-1 drugs primarily used to treat Type 2 diabetes and to lose weight.
That said, taking a GLP-1 isn't the only risk factor for NAION. Some patients already have an elevated risk, including those who have a small optic disc or conditions like diabetes or high blood pressure. Additionally, experiencing NAION in one eye raises the risk that it will happen to the other eye.
One way that patients can learn more about their risk is to get a routine eye exam to figure out if they have a small optic disc. Melinda Hakim, an ophthalmologist in Los Angeles, told MarketWatch in September that some patients get that exam before starting treatment with a GLP-1.
That said, the risk of NAION is very low for the public, occurring in 8.5 per 10,000 people, according to an observational study published in July. That study also found that the risk increases among men, people older than 50 years old and those with heart disease or other eye conditions.
The regulatory change isn't expected to have an impact on GLP-1 usage in the U.S., according to BMO Capital Markets analyst Evan David Seigerman.
"Given the limited incidence of events and unclear increased risk relative to other diabetes therapies, we expect today's GLP-1 labeling update is unlikely to temper incretin sales going forward," Seigerman wrote in a note to investors. "We emphasize the rarity of these events and continue to believe that use of GLP-1s under medical supervision remains extremely safe, with a favorable risk/benefit profile for patients."
-Jaimy Lee
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