Washington:The United States has issued new safety warnings for GLP-1 medicines, highlighting a potential increased risk of a rare eye condition that could lead to permanent vision loss. The Food and Drug Administration (FDA) announced on Monday that all approved glucagon-like peptide-1 receptor agonists, including Novo Nordisk's Ozempic and Wegovy, as well as Eli Lilly's Mounjaro and Zepbound, must update their labels to include information about non-arteritic anterior ischemic optic neuropathy (NAION).
According to Anadolu Agency, NAION is a condition that results from reduced blood flow to the front of the optic nerve, typically causing sudden and painless vision deterioration in one eye, which can become permanent. Symptoms may include blurred vision, blind spots, tunnel vision, distorted colors, and reduced central sharpness, often noticeable after waking.
The FDA advises patients to seek medical attention immediately if they experience any sudden or unexplained changes in vision, but does not recommend discontinuing GLP-1 medicines without consulting a healthcare professional. Patients with a history of NAION should discuss treatment risks and benefits with their doctors.
The FDA's decision is informed by clinical trials and various studies. An analysis involving 126 randomized controlled trials with 134,253 patients found 10 probable NAION cases among GLP-1 users, compared to five among placebo recipients and none among those taking other glucose-lowering drugs. This translates to incidence rates of 6.4 cases per 100,000 person-years for GLP-1 users and 3.8 cases per 100,000 person-years for comparison groups.
Another FDA study indicated no significant risk increase when comparing GLP-1 medicines with SGLT-2 inhibitors but noted a higher risk compared to DPP-4 inhibitors. Despite case reports across all GLP-1 products on the market, the review found no biological mechanism explaining the increased risk. Risk factors for NAION include smoking, diabetes, high blood pressure, sleep apnea, anemia, and kidney disease. GLP-1 drugs are increasingly used to treat type 2 diabetes and obesity by mimicking a hormone that regulates blood sugar, appetite, and digestion.