FDA orders Ozempic, Wegovy and Mounjaro labels to warn of risk of vision loss
The US agency cites a higher risk of NAION, which reduces blood flow to the optic nerve; Lilly says it is reviewing the measure, and Novo Nordisk says the data do not prove cause and effect.
Translated from the Portuguese original by the Panorama newsroom. Read in Portuguese
Summary written by the Panorama newsroom from the sources listed below. Facts are attributed to the original publications.
The FDA, the US agency that regulates drugs, now requires manufacturers of GLP-1 agonists, the class of weight-loss pens that includes Ozempic, Wegovy and Mounjaro, to warn on their labels of a higher risk of NAION, a serious eye condition associated with these drugs, according to Folha de S.Paulo.
In NAION (non-arteritic anterior ischemic optic neuropathy), the optic nerve receives less blood, which can impair vision, sometimes permanently. The FDA says it relied on clinical trials, animal experiments and data collected after the products reached the market, such as observational studies and case reports.
A spokesperson for Eli Lilly, whose Zepbound, sold in Brazil as Mounjaro, is the product cited in the warning, said the notice points to no specific finding about the company's drugs and that the company is reviewing the change and will respond soon. Novo Nordisk, maker of Ozempic and Wegovy, believes the data do not show a cause-and-effect relationship and said it remains confident in the balance of benefits and risks of its products.
In 2025, the European Medicines Agency's safety committee estimated that NAION may affect up to 1 in 10,000 people who use semaglutide, the substance in Ozempic, Wegovy and Rybelsus, for a year or more, in the first confirmation of the side effect by a regulator. In Denmark, four patients who lost their vision after using Novo Nordisk pens received compensation.
Also according to Folha, a study published in 2025 of about 175,000 people with diabetes treated with semaglutide and a similarly sized group taking other classes of drugs found that, after two years, the risk of NAION more than doubled among GLP-1 users.