Concern over optic nerve damage in weight-loss drugs: FDA orders warning to be added

In depth

The US Food and Drug Administration (FDA) has ordered a warning to be added to GLP-1 drugs, including Ozempic, Wegovy and Mounjaro, about a possible risk of rare damage to the optic nerve that could lead to sudden and sometimes irreversible vision loss. The directive requires manufacturers to update the safety labels of all drugs in the class, including Zepbound.

The analysis of 126 clinical trials recorded 6.4 cases per 100,000 treatment years, compared with 3.8 in the comparison groups. However, the condition, called NAION, is extremely rare: only 15 cases were found among more than 134,000 participants. Representatives of the maker of Ozempic said the data do not prove a cause-and-effect relationship.

The FDA does not recommend stopping treatment across the board. Experts said patients should consult a doctor before any discontinuation, and that stopping treatment could lead to weight gain. The symptom that is important to recognize and to seek immediate medical examination for is sudden vision loss in one eye.