FDA Requests Eli Lilly and Novo Nordisk to Remove Suicide Warnings from GLP-1 Drug Labels

The US FDA has asked Novo Nordisk and Eli Lilly to remove warnings about suicidal ideation or behavior from labels of GLP-1 weight-loss drugs including Wegovy, Saxenda, and Zepbound1234

FDA's comprehensive review, including a meta-analysis of 91 placebo-controlled trials with over 108,000 patients, found no increased risk of suicidal thoughts, behaviors, or other psychiatric events like anxiety or depression12

The decision aims to ensure consistent labeling across all GLP-1 receptor agonists, as diabetes-approved GLP-1s lacked such warnings134

Novo Nordisk welcomed the FDA's recommendation, affirming the safety of their GLP-1 medicines when used as indicated2

This follows investigations prompted by 2023 reports, with preliminary FDA findings in January 2024 also showing no causal link234

Sources:

1. https://www.medicalbrief.co.za/fda-asks-drugmakers-to-remove-suicide-warnings-from-glp-1-labels/

2. https://www.biospace.com/fda/fda-asks-novo-lilly-to-remove-suicide-warnings-from-glp-1-weight-loss-products

3. https://www.axios.com/2026/01/13/fda-wegovy-zepbound-suicide-warnings

4. https://abcnews.go.com/Business/wireStory/popular-weight-loss-drugs-carry-suicide-warnings-fda-129182149