In January 2026 the FDA asked the makers of Wegovy, Zepbound and Saxenda to remove the suicidal behavior and ideation warning from their weight-management labels, after reviewing a meta-analysis of 91 clinical trials and a large claims-data study. The Wegovy and Zepbound labels now list that section as removed. FDA’s message to patients, as reported, is to keep taking prescribed medicine and to raise any concerns with a clinician. Mood changes on any medicine are still worth reporting; if you are in crisis, call or text 988 in the U.S.
What changed in the labels
Earlier weight-management labels for these medicines carried a Warnings and Precautions section on suicidal behavior and ideation. The current Wegovy label (revised 06/2026) lists “Suicidal Behavior and Ideation (5.10)” as removed in 01/2026, and the current Zepbound label (revised 08/2026) lists the same section as removed in 02/2026. The Foundayo label (revised 07/2026) does not carry a suicidal-ideation warning section in the parts we reviewed.
What the FDA reviewed
According to Healio’s report on the FDA announcement, the agency looked at two bodies of evidence. The first was a meta-analysis of 91 clinical trials with 107,910 participants (60,338 on a GLP-1 and 47,752 on placebo), which found no increased risk of suicidal ideation or behavior, or of other relevant psychiatric adverse events, compared with placebo. The second was a retrospective study using the FDA’s Sentinel System of 2,243,138 adults with type 2 diabetes who started a GLP-1 or an SGLT2 inhibitor between October 2015 and September 2023, which found no increased risk of intentional self-harm with GLP-1s, including in a subgroup with obesity.
The same report notes that the change applied to the GLP-1s approved for obesity, and that labels for GLP-1s approved for type 2 diabetes did not include this warning. It also notes that FDA’s preliminary look in January 2024 had said an increased risk could not be ruled out at that time. The 2026 conclusion reflects the larger review.
What this does and does not mean
Removing a warning is a statement that the reviewed data did not show a signal. It is not a promise that no individual will ever experience a change in mood. Weight-loss treatment, rapid body change, an underlying mood condition, and many other medicines can all coincide with changes in mood, and population studies cannot rule out an individual reaction.
Two practical points follow. First, you do not need to stop a prescribed medicine because of this older warning; FDA’s reported advice is to continue and discuss concerns with your clinician. Second, tell your prescriber if you have a history of depression or other mood conditions, or if your mood changes after starting, so it can be tracked like any other effect.
If you or someone you know is struggling
In the U.S., you can call or text 988, the Suicide & Crisis Lifeline, at any time. If there is immediate danger, call 911.
Questions to ask your prescriber
- Given my mood history, is there anything you want me to watch for?
- Who should I contact, and how quickly, if my mood changes?
- Do my other medicines have mood-related warnings I should know about?
For other label warnings still in force, see our guides on the thyroid C-cell tumor boxed warning, pancreatitis, and gallstones.
Common misunderstandings
- “The label change means FDA stopped caring about mood effects.” It means FDA concluded the reviewed data did not support the warning.
- “Older articles are still right.” Pages written before 2026 may still describe the removed warning.
- “This applies to every GLP-1.” The change concerned the obesity-indicated labels named above.
Questions people ask
Which labels removed the warning?
Wegovy (removed 01/2026) and Zepbound (removed 02/2026) per their current labels; FDA also requested the change for Saxenda.
Should I stop my medicine if I feel low?
Do not stop a prescribed medicine without talking to your prescriber, but do contact them promptly about mood changes. In a crisis, call or text 988.
Sources
- U.S. FDA labeling, Wegovy prescribing information (revised 06/2026), Recent Major Changes, checked 8 October 2026.
- U.S. FDA labeling, Zepbound prescribing information (revised 08/2026), Recent Major Changes, checked 8 October 2026.
- U.S. FDA labeling, Foundayo prescribing information (revised 07/2026), checked 8 October 2026.
- Healio, FDA asks for removal of suicidal ideation risk from GLP-1 labels following investigation (secondary report of the FDA announcement; the FDA notice itself could not be retrieved in this check).
Medical disclaimer. This article is informational and is not medical advice. Do not start, stop or change a prescribed medicine without instructions from your prescriber. If you are in crisis, call or text 988 (U.S.) or call 911.
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