OMM Newsroom
The US has ordered updated safety warnings for widely used GLP-1 medicines after identifying a possible increased risk of a rare but serious eye condition that can cause permanent vision loss, Anadolu Agency reported.
The Food and Drug Administration (FDA) requirement applies to all approved glucagon-like peptide-1 receptor agonists, including “Ozempic” and “Wegovy” from “Novo Nordisk”, and “Mounjaro” and “Zepbound” from “Eli Lilly”.
Manufacturers must add information about non-arteritic anterior ischemic optic neuropathy, known as NAION, to the “Warnings and Precautions” section of the medicines’ labels, the FDA said in a drug safety communication.
NAION occurs when blood flow to the front of the optic nerve is reduced. It usually causes sudden, painless deterioration of vision in one eye and can lead to permanent sight loss.
Possible symptoms include blurred vision, blind spots, tunnel vision, distorted colors and reduced central sharpness. Symptoms may first become noticeable after waking.
The FDA advised patients to contact a healthcare professional immediately if they experience sudden or unexplained changes in vision. It did not advise patients to stop taking GLP-1 medicines without medical guidance.
People who have previously experienced NAION should discuss with their doctors whether the benefits of continuing treatment outweigh the possible risks, the agency said.
The FDA based its decision on clinical trials, post-market reports, observational studies and real-world health data.
An analysis of 126 randomized controlled trials covering 134,253 patients identified 10 probable NAION cases among people using GLP-1 medicines, compared with five among patients receiving a placebo and none among those using other glucose-lowering drugs.
The incidence rates were 6.4 cases per 100,000 person-years among GLP-1 users and 3.8 cases per 100,000 person-years in the comparison groups.
A separate FDA study found no statistically significant increase when GLP-1 medicines were compared with SGLT-2 inhibitors, another class of diabetes drugs. However, it found a higher risk when they were compared with DPP-4 inhibitors.
The agency said cases had been reported across all GLP-1 products currently on the US market, although its review of animal data did not identify a biological mechanism explaining how the medicines might increase the risk.
Smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease are among the existing risk factors for NAION. People who experience the condition in one eye are also at greater risk of developing it in the other.
GLP-1 medicines mimic a hormone involved in regulating blood sugar, appetite and digestion. Their use has increased rapidly for the treatment of type 2 diabetes and obesity.
