FDA Requests Removal of Suicidal Behavior and Ideation Warning From GLP-1 Receptor Agonist Labels

In a Drug Safety Communication dated January 13, 2026, the FDA said its comprehensive review did not identify an increased risk of suicidal ideation or behavior with GLP-1 receptor agonists. The agency therefore requested that application holders remove that warning language from the labeling of Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide).

According to the FDA, the review rested on two main pieces of evidence: a meta-analysis of 91 placebo-controlled trials and a Sentinel System cohort study. The agency stated that, taken together, that work did not identify the increased risk that the warning language had described.

The scope of the action matters. This was a labeling request following a safety review of one specific concern, suicidal ideation and behavior. It was not a finding that these drugs are risk-free, and the FDA conclusion should not be generalized beyond the specific concern the agency reviewed.

The request was also not an endorsement of any product. Each named product remains approved only as the specific drug product on its own label and for its own labeled indication, and nothing in this communication changes the regulatory status of compounded or research-grade versions of these molecules.