Rafferty Domnick Cunningham & Yaffa Spotlights Critical Patient Safety Concerns Following FDA GLP-1 Warning

FDA Requires New Safety Labeling for Popular Diabetes and Weight-Loss Medications Following Review of Potential Risk of Permanent Vision Loss

WEST PALM BEACH, Fla., Nov. 10, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications to update their safety labeling to include a potential increased risk of a rare but serious eye condition that can cause permanent vision loss.

The FDA issued its safety communication on November 9, identifying a potential association between GLP-1 medications and non-arteritic anterior ischemic optic neuropathy (NAION). The condition occurs when blood flow to the optic nerve is reduced and can result in sudden, painless vision loss in one eye.

The new labeling requirements apply to the entire class of GLP-1 medications, including widely prescribed drugs such as Ozempic, Wegovy, Mounjaro and Zepbound, which are commonly used to treat Type 2 diabetes and manage obesity.

As part of its analysis, the FDA pooled 126 randomized clinical trials involving more than 134,000 patients. According to the FDA, NAION occurred at a rate of 6.4 cases per 100,000 person-years among patients taking GLP-1 medications, compared with 3.8 cases per 100,000 person-years among patients in comparison groups, who received a placebo or a non-GLP-1 glucose-lowering medication.

"Patients deserve to know about the potential risks associated with the medications they take, especially when those risks involve the possibility of permanent vision loss," said Katherine A. Kiziah, a partner at Rafferty Domnick Cunningham & Yaffa who focuses her practice on complex pharmaceutical, medical device and product liability litigation. "The FDA's decision to require updated warnings across the entire class of GLP-1 medications underscores the importance of continued safety monitoring and transparency. When new safety concerns emerge, patients need clear information so they can have informed conversations with their health care providers about their treatment options."

What Patients Should Know

NAION is a rare condition that can cause sudden, painless vision loss in one eye, sometimes first noticed upon waking. Other symptoms can include blurred vision, blind spots, tunnel vision, distorted colors or hazy areas affecting central vision.

The FDA advises patients experiencing sudden vision changes or other symptoms associated with NAION to contact their health care professional immediately. Patients who experience a NAION event should speak with their provider about whether to continue or discontinue their GLP-1 medication rather than making that decision independently.

The agency is also advising health care professionals to discuss the potential risk with patients, promptly refer individuals with suspected NAION to an ophthalmologist and consider discontinuing GLP-1 treatment in patients who develop the condition unless the benefits of treatment clearly outweigh the risks.

"The fact that a medication has been approved and is widely prescribed does not mean its safety profile should stop being evaluated," Kiziah added. "Pharmaceutical manufacturers have an ongoing responsibility to monitor emerging safety information, and patients should be made aware of significant developments that could affect their health. This is particularly important as medications become increasingly popular and are prescribed to larger patient populations."

For more information about the FDA's website: here.

About Rafferty Domnick Cunningham & Yaffa

Rafferty Domnick Cunningham & Yaffa is a leading Florida law firm dedicated to advocating for victims of mass torts, medical malpractice and corporate negligence. With a track record of holding powerful institutions accountable, the firm fights for justice on behalf of individuals and families affected by preventable harm.

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