FDA Requires Novo Nordisk to Add Vision Warning to Ozempic, Wegovy

The U.S. Food and Drug Administration (FDA) is requiring Novo Nordisk to add a warning about a potential increased risk of a serious eye condition to the labels of its popular GLP-1 drugs, including Ozempic and Wegovy. The regulatory action affects all drugs in the GLP-1 class, including those from competitor Eli Lilly.

The condition, non-arteritic anterior ischemic optic neuropathy (NAION), can cause sudden, permanent vision loss. The FDA’s decision follows a review of adverse event reports and clinical trial data.

The labeling update adds to the legal and clinical scrutiny facing the widely used diabetes and weight-loss treatments. Some patients have filed lawsuits alleging vision impairment. Drugmakers say a direct causal link has not been proven.