FDA warns of risk of vision loss with Ozempic and other weight-loss drugs

The US Food and Drug Administration (FDA) has asked manufacturers of GLP-1 diabetes and obesity drugs to add a warning about the possible increased risk of a rare optic nerve disease that can lead to permanent vision loss. The decision concerns, in particular, the drugs Ozempic, Wegovy, Mounjaro and Zepbound.

According to the FDA, this is non-arteritic anterior ischemic optic neuropathy (NAION). This disease is caused by disruption of the blood supply to the optic nerve and can cause sudden, usually painless loss of vision in one eye, including permanent blindness.

The decision was made based on the results of an analysis of 126 randomized clinical trials involving more than 134 thousand people. Among patients receiving GLP-1 drugs, the incidence of the disease was 6.4 cases per 100 thousand patient-years, while in control groups it was 3.8 cases. In total, the studies identified 15 probable cases of the disease: ten among those taking GLP-1 drugs and five in control groups.

The FDA emphasizes that this is a very rare complication. However, data from observational studies indicate a possible increase in risk, although the exact biological mechanism of this association has not yet been established. The observed statistical effect alone does not mean that each drug directly causes damage to the optic nerve.

The regulator advises patients to seek immediate medical attention if there is sudden deterioration in vision, blind spots, color disturbances or blurred vision. If NAION is suspected, an urgent examination by an ophthalmologist is necessary. The decision to stop taking the drug should be made together with your doctor.

Novo Nordisk, which makes Ozempic and Wegovy, said available scientific evidence does not prove a cause-and-effect relationship between semaglutide and optic nerve damage. Representatives for Eli Lilly, which makes Mounjaro and Zepbound, said they are studying the new FDA requirements.

Drugs of the GLP-1 family are widely used to control blood sugar levels in type 2 diabetes and reduce body weight. The American regulator did not demand the cessation of their use, limiting itself to introducing additional warnings about the possible risk.