FDA Announces Warning Of “Rare But Serious” Condition Associated With GLP-1 Weight Loss Medications

image-44.jpg

The Food and Drug Administration (FDA) on Monday issued a new warning on GLP-1 weight loss medications, saying there is a “potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION).”

“NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss,” the FDA stated.

“The FDA is warning that GLP-1 drugs like Ozempic and Zepbound can decrease blood flow to the optic nerve, increasing the risk of vision loss,” CBS Evening News stated.

Watch below:

The FDA is warning that GLP-1 drugs like Ozempic and Zepbound can decrease blood flow to the optic nerve, increasing the risk of vision loss. pic.twitter.com/wFNG00PR6p

— CBS Evening News with Tony Dokoupil (@CBSEveningNews) November 10, 2026


More from The Guardian:

Common risk factors of NAION include diabetes, smoking, hypertension, as well as hypercholesterolemia. It is the most common cause of acute optic nerve injury in individuals over 50 years old, with an annual average of 2.3 to 10.2 cases out of 100,000 people above that age. There is for now no treatment to reverse vision loss from NAION.

According to the FDA, the agency began looking at potential links between GLP-1s and NAION after a 2024 study published in the journal JAMA Ophthalmology. The study found an increased risk of NAION among patients using GLP-1 medications.

Despite identifying several limitations of the study, the FDA said it “determined that further assessment of the potential increased risk for NAION was warranted”.

The agency proceeded to review 126 clinical trials involving over 134,200 patients and identified 15 probable NAION cases, including 10 among GLP-1 patients; five in patients receiving placebo; and none in patients who were on glucose-lowering medications that were not GLP-1.

The FDA found a NAION incidence rate of 6.4 cases per 100,000 person-years among GLP-1 patients, compared to 3.8 cases among patients on placebo or alternative glucose-lowering medications.

“The agency is requiring application holders for all GLP-1 RA medications to add information to the Warnings and Precautions section of labeling about the potential increased risk of NAION associated with use of these medications,” the FDA stated.

Information about the potential risk will be added to medications such as Novo Nordisk’s Ozempic and Wegovy; Eli Lilly’s Mounjaro and Zepbound; and Sanofi’s Soliqua.

The US health regulator on Monday informed patients and healthcare providers of a potential increased risk of a serious eye condition associated with the use of ‌GLP-1 drugs for weight loss and diabetes. https://t.co/TsyFoYwc7L

— CNN (@CNN) November 9, 2026


BBC shared further:

In a statement to the BBC, the American Academy of Ophthalmology said “any added risk appears small, and it has not been established that these medications cause NAION”.

“GLP-1 medications offer important benefits for people with diabetes, obesity, and heart disease, so our message to patients is simple,” the group said. “Don’t stop your medication without talking to your doctor, and if you notice sudden, painless vision loss in one eye, see an ophthalmologist promptly.”

There is no known treatment to reverse vision loss caused by NAION. It is the most common cause of acute optic nerve injury in people over 50 years old, according to the academy.

The FDA said it conducted a detailed review of reports of NAION in GLP-1 users as well as a review of other studies and concluded there is an “increased risk of rare NAION events” in people taking the drugs.

In a statement, Novo Nordisk, the manufacturer of Wegovy, one of the most popular weight-loss medications, said the company believes the data “do not establish a cause-and-effect relationship”.

“We recognize that NAION can have a profound impact on patients and their families. Patient safety is a top priority for Novo, and we continue to monitor the safety of our medicines,” the manufacturer said.

Some research was challenging to review because people taking GLP-1 drugs for obesity and type 2 diabetes may already have risk factors for NAION separate from the drugs, according to the regulator. The FDA said it was not known why those taking GLP-1 drugs may be more at risk for the eye condition.

Watch additional coverage below:


The post FDA Announces Warning Of “Rare But Serious” Condition Associated With GLP-1 Weight Loss Medications appeared first on 100PercentFedUp.com.

Continue reading...

[H/T 100PercentFedUp]

Comments

There are no comments to display
Back
Top