The U.S. Food and Drug Administration is requiring manufacturers of GLP-1 drugs like Ozempic and Wegovy to put warning labels on their packaging, cautioning users that the drugs can cause sudden vision loss and other problems.
The warning applies to all GLP-1 drugs, including those used for treatment of diabetes as well as weight loss. The agency said there is a slight risk that the medication can cause a loss of blood flow to the optic nerve, causing sudden and painless vision loss.
The condition is called non-arteritic ischemic optic neuropathy (NAION).
The warning follows a review of 126 randomized clinical trials involving more than 134,000 patients. The study identified about 2.6 additional cases per 100,000 person-years. That’s a small risk but with millions of people using GLP-1, patients and their doctors need to know about it.
What to do
Even though the risk is quite small, patients should be alert for warning signs, which include sudden painless vision loss in one eye, blind spots, tunnel vision, changes in color perception and blurred central vision.
Anyone who experiences these symptoms should seek immediate medical help. Treat it as an emergency, not something you’ll take care of tomorrow.
Notice that the FDA is not recommending that you stop taking GLP-1 drugs. The risk, as in all medication decisions, must be considered alongside the benefits, which can include better diabetes control, weight loss and reduced cardiovascular risks in some patients.
The warning follows lawsuits
The FDA’s action comes after a wave of lawsuits that charged drug manufacturers did not adequately warn consumers about serious side effects of GLP-1 drugs, including not only vision loss but also severe gastrointestinal complications allegedly linked to the medications, including gastroparesis, also known as stomach paralysis.
Plaintiffs in some of the cases claim they suffered debilitating nausea, vomiting, dehydration, malnutrition, intestinal blockages and repeated hospitalizations after taking the drugs. Some lawsuits allege the injuries became permanent.
Other cases included NAION, the risk cited in today’s FDA warning, sometimes described as an “eye stroke.”
Legal filings and court records indicate that the litigation has grown into one of the largest emerging pharmaceutical mass torts in the country, with additional lawsuits expected as awareness of the alleged injuries spreads.
Attorneys representing plaintiffs argue that stronger warnings could have changed prescribing decisions or prompted consumers to seek treatment earlier.
“This litigation is fundamentally about informed consent,” several complaints argue in varying language. “Patients cannot weigh risks they were never clearly told about.”