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FDA Seeks Removal of Suicide Warnings From Saxenda, Wegovy and Zepbound

The move follows FDA analyses of 91 trials plus a 2.24 million‑patient claims study that found no increased risk.

FILE - Boxes for the medications Wegovy and Zepbound are arranged for a photograph in California, May 8, 2025. (AP Photo/JoNel Aleccia, File)
Image
Zepbound, Wegovy, and Saxenda's labels will now be updated after the FDA's request. Ciara Kimsey via Shutterstock.com.

Overview

  • The agency asked manufacturers to strike suicidal ideation and behavior warnings from the labels of the three GLP-1 drugs approved for weight loss.
  • A meta-analysis covering 91 placebo-controlled trials with 107,910 participants found no elevated risk of suicidal thoughts, behaviors, or other psychiatric adverse events versus placebo.
  • An FDA Sentinel retrospective cohort study of 2,243,138 adults comparing GLP-1 users with SGLT2 inhibitor users found no increased risk of intentional self-harm, including in patients with type 2 diabetes and obesity.
  • The labeling change applies only to obesity indications, as diabetes-approved GLP-1 products did not carry suicide-risk warnings, and the FDA advises patients to continue therapy and discuss concerns with clinicians.
  • Eli Lilly and Novo Nordisk welcomed the request and said they will work with the FDA on updates, a stance consistent with the UK regulator’s 2024 finding of no link to suicidality.