FDA wants suicide warning removed from Saxenda, Wegovy and Zepbound labels

The FDA is asking the companies that make three GLP-1 weight-loss medicines to delete the suicidal thoughts and behavior warning from their prescribing labels, after concluding that the drugs do not raise that risk ^[1][6]. The products named in the agency's Jan. 13, 2026 drug safety communication are Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide) ^[1][6].

What the agency reviewed

FDA combined 91 placebo-controlled trials of GLP-1 receptor agonists for a meta-analysis of 107,910 patients — 60,338 on a GLP-1 drug and 47,572 on placebo ^[1][6]. The pooled results showed no elevated risk of suicidal ideation or behavior, and no elevated risk of anxiety, depression, irritability or psychosis ^[1][6]. The agency said its first look at the trial data left too few cases to pin down the risk estimate, which is why it pooled data across drug development programs ^[1][6].

A second analysis used claims from the FDA Sentinel System to compare people with type 2 diabetes starting a GLP-1 against people starting an SGLT2 inhibitor. That study covered 2,243,138 patients (1,161,983 on a GLP-1, 1,081,155 on an SGLT2 inhibitor) across 10 data partners between Oct. 1, 2015 and Sept. 20, 2023 ^[1][6]. Intentional self-harm was not more common among GLP-1 users, including among those who also had obesity ^[1][6].

FDA also examined published observational and pooled studies and said the total body of evidence does not support a causal link between these medicines and suicidal ideation or behavior ^[1][6].

How the warning got there

The three products have carried the language in their Warnings and Precautions sections since they were first approved, and FDA says it was drawn from suicidal events reported with a range of older weight-loss medicines rather than from these drugs ^[1][2]. Diabetes-only GLP-1 labels never included it; the agency said removing it from the weight-loss products will align messaging across the class ^[1][6].

The agency opened its investigation in July 2023 after postmarketing reports of suicidal ideation and behavior in patients taking GLP-1 medicines ^[1][6]. Its January 2024 update said the preliminary look found no association but could not rule out a small risk given how few cases had surfaced ^[1][4]. A Reuters review of the FDA adverse-event database in 2023 counted 265 reports of suicidal thoughts or behavior in patients taking these or similar drugs since 2010 ^[2].

Novo Nordisk, which sells Saxenda and Wegovy, said it welcomed the recommendation; Eli Lilly, maker of Zepbound, said it appreciates "the FDA's careful consideration of this important safety issue" and will "continue to work with the FDA on next steps to ensure that appropriate safety information is available to prescribers" ^[2]. European labels for these drugs do not carry such warnings ^[2].

Why it matters for patients

The finding covers the drug class, and what changes is the written label, not the medicine itself. FDA said patients should keep taking these drugs as prescribed and raise any concerns with their health care professional ^[1].

FDA still advises telling a health care professional about new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior, and points to the 988 Suicide & Crisis Lifeline, which it describes as free support available 24 hours a day, seven days a week ^[1]. Health care professionals were told to be ready to discuss the review's conclusion and to refer anyone who discloses suicidal thoughts or behavior to a mental health professional for evaluation ^[1][6].

For Zepbound, the change also reaches the Medication Guide that comes with the drug, where "depression or thoughts of suicide" is to be removed from the possible side effects section ^[5].

What happens next

FDA sent Eli Lilly a supplement request letter on Jan. 13, 2026 seeking removal of the suicidal ideation information from the Zepbound label ^[5]. A supplement approval letter signed Feb. 25, 2026 provides for deleting subsection 5.9, Suicidal Ideation and Behavior, from Warnings and Precautions and for the matching Medication Guide edit ^[5]. That same supplement added label language about postmarketing reports of intestinal obstruction and severe constipation including fecal impaction ^[5].

When the labels for Saxenda and Wegovy will change has not been reported.