According to reporting by Reuters, the U.S. Food and Drug Administration has asked drugmakers to remove warnings about suicidal thoughts from the labels of widely used weight-loss medications after concluding that available evidence does not support a causal link. The decision follows a review of clinical trial data and post-marketing reports involving drugs such as Novo Nordisk’s Wegovy and Ozempic, as well as Eli Lilly’s Zepbound and Mounjaro.
Regulators said their assessment found no clear signal showing that the medicines increase the risk of suicide or self-harm. The FDA emphasized that large-scale trials and real-world safety monitoring did not demonstrate a higher incidence of such behaviors compared with placebo or other treatments. The agency added that it would continue to track adverse event reports as use of the drugs expands rapidly.
The move comes amid surging demand for GLP-1–based weight-loss and diabetes drugs, which have transformed treatment options for obesity and related conditions. While some European regulators have also reviewed similar safety concerns, U.S. officials said the current scientific evidence does not justify retaining the suicide-related warnings on product labels.
Health experts note that patients with a history of mental health conditions should still be monitored carefully, but welcomed the FDA’s decision as providing greater clarity for doctors and consumers. Drugmakers are expected to update labeling in line with the agency’s request in the coming months.