What the FDA concluded
On 13 January 2026, the FDA asked the makers of Saxenda, Wegovy and Zepbound to remove the "Suicidal Behavior and Ideation" warning from their labels. Its review pooled 91 placebo-controlled trials with 107,910 participants and found no increased risk of suicidal thoughts or behaviour, nor of anxiety, depression, irritability or psychosis. A separate analysis of 2.24 million people with type 2 diabetes in the FDA's Sentinel system found no increase in self-harm compared with another class of diabetes drugs.[1] The current Wegovy and Zepbound labels list that warning as removed.[2][3]
What the trials showed
A pooled analysis of four semaglutide weight trials found new suicidal ideation in 0.4% on semaglutide and 0.6% on placebo, and no clinically meaningful change in depression scores.[4] One label figure points the other way, in a small group: in the adolescent Wegovy trial, anxiety was reported by 4% on the drug against 2% on placebo.[2]
What the data cannot rule out
The weight-loss trials excluded people with recent major depression or suicidal behaviour, so the trial data apply best to people without those histories.[4] Large studies can show that average risk is not raised; they cannot tell an individual that their own change in mood is unrelated. Rapid changes in eating, body and routine can affect mood on their own.
When to get help
- Thoughts of harming yourself: in the US call or text 988 (Suicide and Crisis Lifeline), or emergency services
- Low mood, loss of interest or anxiety lasting more than two weeks: tell your prescriber
- A history of depression or an eating disorder: worth raising before starting, not after
Heard vs evidence
The short version
Short on the way. A 35-second captioned version of this page is in production for the Fewer Bites channel. It will be embedded here when it is live.
Questions to bring to your prescriber
Print these or screenshot them. They are conversation starters, not a checklist of things to do.
- Given my mental-health history, is there anything you want to monitor while I am on this medicine?
- If I notice low mood or anxiety, who should I contact first?
- Are any of my other medicines affected by eating much less?
Education, not advice. This page explains what trials, labels and guidelines report. It does not tell anyone to start, change or stop a medicine. Your prescriber knows your history; this page does not.
Sources
- US FDA. Drug Safety Communication: FDA requests removal of suicidal behavior and ideation warning from GLP-1 receptor agonist medicines, 13 January 2026. primary read · regulator review
- Novo Nordisk / FDA. Wegovy (semaglutide) injection and tablets, prescribing information, revised 06/2026. label
- Eli Lilly / FDA. Zepbound (tirzepatide) prescribing information, revised 08/2026. label
- Wadden TA et al. Psychiatric safety of semaglutide for weight management: post hoc analysis of STEP 1, 2, 3 and 5. JAMA Intern Med 2024. abstract only · post hoc of RCTs · industry-funded