FDA asks makers of Saxenda, Wegovy and Zepbound to drop suicide warning
The FDA found no increased suicide risk across 107,910 patients in GLP-1 trials and asked three weight-loss drug makers to drop the warning from their labels.
The FDA has asked the makers of Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide) to remove suicidal ideation and behavior from the warnings section of their labels, saying a large review found no increased risk of those events with GLP-1 receptor agonist medicines [2]. The request came in a Drug Safety Communication dated January 13, 2026 [2].
The three products are each approved for weight reduction in people with obesity or overweight, and each carried the warning at the time of its original approval [2]. Similar language appears on other weight-loss medicines and is based on reports seen with older weight-loss drugs, according to the FDA [2]. Labels for GLP-1 medicines approved to treat type 2 diabetes do not currently carry the suicidal ideation and behavior language, and the agency said its action would make messaging consistent across the class [2].
The FDA's conclusion rests on two main analyses. The first was a meta-analysis of 91 placebo-controlled GLP-1 trials with 107,910 patients: 60,338 treated with a GLP-1 medicine and 47,572 given placebo [2]. Results showed no increased risk of suicidal ideation or behavior, and no increased risk of other psychiatric events the agency tracked, including anxiety, depression, irritability and psychosis [2]. The second was a retrospective cohort study using FDA Sentinel System claims data that compared new users of GLP-1 medicines with new users of SGLT2 inhibitors in patients with type 2 diabetes [2]. That study covered 2,243,138 people — 1,161,983 starting a GLP-1 medicine and 1,081,155 starting an SGLT2 inhibitor — across 10 data partners between October 1, 2015, and September 20, 2023 [2]. After adjusting for baseline differences, the FDA found no increased risk of intentional self-harm in the GLP-1 group, including in the subgroup of patients who had both type 2 diabetes and obesity [2]. The agency also reviewed published observational and pooled studies and said the totality of the evidence does not support a causal relationship [2].
The FDA opened its investigation in July 2023 after postmarketing reports of suicidal ideation and behavior in patients taking GLP-1 medicines, and published preliminary findings in a January 2024 safety communication [2]. That earlier review found no association, but the small number of cases in individual trials left substantial uncertainty, which the larger meta-analysis was designed to address [2].
Label records reflect the change. Wegovy's prescribing information lists "Suicidal Behavior and Ideation (5.10)" as "(Removed) 01/2026" in its Recent Major Changes section, in a document revised 06/2026 [1]. A DailyMed version of the Wegovy label instead lists the same entry as "(Removed) 02/2026" [3], so the two label records disagree on the month for Wegovy. Zepbound's prescribing information lists "Suicidal Behavior and Ideation (Removed) 02/2026" in a document revised 8/2026 [4]. Whether Saxenda's label has been updated has not been disclosed in these materials.
The boxed warnings for thyroid C-cell tumors remain on both Wegovy and Zepbound, along with other warnings such as pancreatitis, gallbladder disease, kidney injury from volume depletion, severe gastrointestinal reactions and hypoglycemia when used with insulin or insulin secretagogues [1][4].
Why it matters for patients
Warnings on a drug label shape how doctors counsel patients and how patients weigh risks. For someone who stopped a GLP-1 medicine or hesitated to start one because of the suicide warning, the label no longer lists that risk. The FDA said patients should keep taking their medication as prescribed and discuss any concerns with their health care professionals [2]. The agency also said health care professionals should be ready to explain that the review found no increased risk, and should refer anyone reporting suicidal thoughts or behavior to a mental health professional for evaluation [2]. The FDA continues to direct people in distress to the 988 Suicide and Crisis Lifeline, available by call or text 24 hours a day [2].
Removing a warning does not mean mood changes are meaningless. The FDA advises telling a health care professional about new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior [2].
What happens next
The FDA asked the three companies to remove the labeling language; the Wegovy and Zepbound label records show removals dated January and February 2026 [2][1][4]. Timing for any Saxenda label change has not been reported. Side effects can be reported to the FDA MedWatch program [2].
Sources
- https://www.novo-pi.com/wegovy.pdf
- https://www.fda.gov/drugs/drug-safety-communications/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
- https://uspl.lilly.com/zepbound/zepbound.html
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