Semaglutides
FDA & regulation

Suicidal behavior and ideation warning removed from the Wegovy label

FDA reviewed 91 placebo-controlled trials with 107,910 participants, found no increased risk of suicidal thoughts or behavior, and asked Novo Nordisk and Eli Lilly to drop that warning from Wegovy, Zepbound and Saxenda.

By the Semaglutides news desk··Wegovy

The FDA said on January 13, 2026 that it is asking the companies behind three obesity drugs — Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide) — to remove the warning about suicidal ideation and behavior from their prescribing information, after a large agency review found no increased risk [2]. The Wegovy label now lists "Suicidal Behavior and Ideation (5.10)" in its Recent Major Changes section marked "(Removed)" [1].

What the FDA reviewed

The warning was not based on GLP-1 trial results in the first place. FDA says similar language appears on other weight-loss drug labels and came from reports seen with "a variety of older medicines used or studied for weight loss" [2]. GLP-1 drugs approved for type 2 diabetes — not obesity — never carried the language, so the agency framed this change as making labeling consistent across the class [2].

FDA opened its investigation in July 2023 after postmarketing reports of suicidal thoughts and actions in people taking GLP-1 medicines, and published a preliminary update on January 30, 2024 [2]. That early look found no association, but individual trials had too few cases to be sure [2].

To sharpen the estimate, FDA ran a meta-analysis pooling 91 placebo-controlled GLP-1 trials covering 107,910 patients — 60,338 on a GLP-1 receptor agonist and 47,572 on placebo [2]. The results showed no increased risk of suicidal ideation or behavior, and no increase in other psychiatric events such as anxiety, depression, irritability or psychosis [2].

FDA also ran a retrospective cohort study in its Sentinel System using health insurance claims, comparing new users of GLP-1 drugs with new users of SGLT2 inhibitors among people with type 2 diabetes. That analysis included 2,243,138 people — 1,161,983 starting a GLP-1 and 1,081,155 starting an SGLT2 inhibitor — drawn from 10 data partners between October 1, 2015 and September 20, 2023 [2]. After adjusting for baseline differences, the agency found no increased risk of intentional self-harm with GLP-1 drugs, including in the subgroup of patients who had both type 2 diabetes and obesity [2]. A review of published observational and pooled studies concluded the overall evidence "does not support a causal relationship" [2].

What the labels show

The Wegovy prescribing information posted by Novo Nordisk dates the removal to 01/2026 [1]. The Wegovy label on DailyMed lists the same removal as 02/2026 [3]. The Zepbound label's Recent Major Changes table also records "Suicidal Behavior and Ideation (Removed)" as 02/2026 [4]. The sources disagree on the exact month the change took effect in each label version; the FDA communication itself is dated January 13, 2026 [2].

Other warnings stay in place. Wegovy keeps its boxed warning about thyroid C-cell tumors seen in rodents, plus warnings on pancreatitis, gallbladder disease, hypoglycemia when combined with insulin or insulin secretagogues, kidney injury from volume depletion, severe gastrointestinal reactions, hypersensitivity, diabetic retinopathy complications, heart rate increase, and aspiration during anesthesia [1][3]. Zepbound retains its own boxed warning and a similar warnings list [4].

Why it matters for patients

For people already taking these drugs, nothing about dosing or availability changes. FDA's guidance was that patients "should continue taking their medication as prescribed and discuss any concerns with their health care professionals" [2].

The practical effect is on the conversation. The Medication Guide and the Warnings and Precautions section are what many people read before starting, and a warning about suicidal thoughts has been a reason some patients and prescribers hesitated. FDA now says clinicians "should be prepared to discuss with patients that FDA has found no increased risk after conducting a comprehensive review of the available data" [2].

Removing a label warning is not the same as saying mood changes never happen. FDA still tells patients to report new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior to a health care professional, and points to the 988 Suicide and Crisis Lifeline, available by call or text 24 hours a day [2]. Clinicians are told to refer anyone disclosing suicidal ideation or behavior to a mental health professional [2].

What happens next

FDA issued the request on January 13, 2026 [2]. Label updates follow on each sponsor's timeline: Wegovy's own prescribing information dates the removal to 01/2026 [1], while DailyMed and the Zepbound label show 02/2026 [3][4]. Printed materials, pharmacy handouts and third-party drug references may take longer to catch up. FDA continues to collect reports through MedWatch [2].

Sources

  1. https://www.novo-pi.com/wegovy.pdf
  2. https://www.fda.gov/drugs/drug-safety-communications/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp
  3. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
  4. https://uspl.lilly.com/zepbound/zepbound.html

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