The FDA is requesting that drugmakers remove suicidal ideation and behavior warnings from the labeling of three GLP-1 receptor agonists — Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide) — effective Jan. 13, 2026.
The FDA’s decision follows a meta-analysis of 91 placebo-controlled trials comprising 107,910 patients, according to a Jan. 13 FDA news release. Of those, 60,338 received a GLP-1 receptor agonist and 47,572 received a placebo. The analysis did not identify an increased risk of suicidal thoughts, behaviors or other psychiatric events such as anxiety, depression, irritability or psychosis.
The agency also conducted a retrospective cohort study comparing more than 2.2 million new users of GLP-1 receptor agonists and SGLT2 inhibitors between 2015 and 2023. After adjusting for baseline differences, the FDA found no elevated risk of intentional self-harm among GLP-1 users, including patients with both Type 2 diabetes and obesity.
The warning language was originally included based on earlier concerns and past reports associated with older weight loss drugs. Labeling for GLP-1 receptor agonists approved solely for Type 2 diabetes has not carried the same warnings.
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