--- title: FDA Asks Companies to Remove Suicide Risk Warning From GLP-1 RA Labels description: The FDA requested that manufacturers of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for weight loss remove warnings that the drugs may increase the risk of suicidal ideation and behavior. image: https://alert.psychnews.org/hubfs/Imported_Blog_Media/glp_pens_iStock-2241146296.jpg --- 1/15/26 1:26 PM # FDA Asks Companies to Remove Suicide Risk Warning From GLP-1 RA Labels ![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [ Psychiatric News Alert ](https://alert.psychnews.org/author/psychiatric-news-alert) Share: [facebook-f icon ](http://www.facebook.com/share.php?u=https://alert.psychnews.org/fda-asks-companies-to-remove-suicide-risk-warning-from-glp-1-ra-labels) [linkedin-in icon ](http://www.linkedin.com/shareArticle?mini=true&url=https://alert.psychnews.org/fda-asks-companies-to-remove-suicide-risk-warning-from-glp-1-ra-labels) [Twitter icon ](https://twitter.com/intent/tweet?url=https://alert.psychnews.org/fda-asks-companies-to-remove-suicide-risk-warning-from-glp-1-ra-labels) [pinterest-p icon ](http://pinterest.com/pin/create/link/?url=https://alert.psychnews.org/fda-asks-companies-to-remove-suicide-risk-warning-from-glp-1-ra-labels) [envelope icon ](mailto:?body=https://alert.psychnews.org/fda-asks-companies-to-remove-suicide-risk-warning-from-glp-1-ra-labels) ![glp_pens_iStock-2241146296](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/glp_pens_iStock-2241146296.jpg?width=220&height=124&name=glp_pens_iStock-2241146296.jpg)The Food and Drug Administration (FDA) this week [requested](https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp) that manufacturers of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for weight loss remove warnings that the drugs may increase the risk of suicidal ideation and behavior.   The affected medications are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide).   **Why It’s Relevant** When these three medications were approved by the FDA to treat obesity, their labels were required to include a warning that they could increase the risk of suicidal ideation and behaviors (SI/B)—a warning also included in the labeling of other types of weight-loss medications due to postmarketing reports of such events. However, the warning about SI/B is not required for GLP-1 drugs solely approved to improve blood-sugar control or other complications in patients with type 2 diabetes.   **By the Numbers** - In [January 2024](https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type), the FDA stated that a review of patient reports and clinical trials did not reveal an association between GLP-1 RAs and SI/B. However, because of the small number of total events, the agency couldn’t definitively rule out a small risk. - Since then, the FDA conducted a meta-analysis of 91 placebo-controlled GLP-1 RA trials, which included 107,910 patients. The results **did not show an increased risk for SI/B or for other relevant psychiatric adverse events such as anxiety, depression, irritability, or psychosis**. - Additionally, the FDA used health care claims data from 2015 to 2023 to compare the risk of intentional self-harm between GLP-1 RAs and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in more than 2.2 million patients with type 2 diabetes. The analysis **did not reveal an increased risk of intentional self-harm** in GLP-1 RA users compared with SGLT2i users after controlling for confounders. **What Else to Know** Researchers are increasingly looking into the use of GLP-1 drugs [within psychiatry](https://alert.psychnews.org/2025/06/researchers-look-to-unlock-glp-1-drugs.html). Semaglutide, for example, has been linked to a [lower risk of Alzheimer’s disease](https://alert.psychnews.org/2024/10/semaglutide-linked-to-lower-risk-of.html) in adults with type 2 diabetes compared with other diabetes drugs.   **Takeaway Message** “Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications,” the FDA stated. “Health care professionals should be prepared to discuss with patients that FDA has found no increased risk [of SI/B] after conducting a comprehensive review of the available data. If individuals disclose that they are experiencing SI/B, refer them to mental health professionals for evaluation.”   **Related Information** “[Blockbuster Weight-Loss Drugs Not Tied to Suicidality, Studies Show](https://psychiatryonline.org/doi/10.1176/appi.pn.2024.06.6.38)”   **Source** FDA requests removal of suicidal behavior and ideation warning from glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. FDA Drug Safety and Availability website. Published January 13, 2026.   (Image: Getty Images/iStock/SweetBunFactory)   | **In Whirlwind Day, SAMHSA Grants Terminated, Then Restored** Late Tuesday, the Substance Abuse and Mental Health Services Administration (SAMHSA) [terminated upwards of $2 billion in grants](https://www.npr.org/2026/01/14/nx-s1-5677104/trump-administration-letter-terminating-addiction-mental-health-grants) to nonprofit programs supporting mental health and substance use care across the United States—including two APA/APA Foundation programs (APA’s [Workforce Development Initiative](https://www.psychiatry.org/Psychiatrists/Diversity/Workforce) and the Foundation's [Notice. Talk. Act.® at School](https://www.apaf.org/our-programs/schools/notice-talk-act-at-school/)). Following bipartisan backlash [from APA](https://www.psychiatry.org/News-room/News-Releases/APA-Statement-on-SAMHSA-Cuts) and many other groups, the Trump administration reversed course last night, announcing funding [had been restored](https://www.npr.org/2026/01/14/nx-s1-5677714/trump-administration-mental-health-addiction-grant-cuts-restored).  | | --- |   [obesity](https://alert.psychnews.org/tag/obesity), [suicidal thoughts](https://alert.psychnews.org/tag/suicidal-thoughts), [FDA](https://alert.psychnews.org/tag/fda), [weight loss](https://alert.psychnews.org/tag/weight-loss), [GLP-1 receptor agonist (GLP-1)](https://alert.psychnews.org/tag/glp-1-receptor-agonist-glp-1), [Ozempic](https://alert.psychnews.org/tag/ozempic), [Zepbound](https://alert.psychnews.org/tag/zepbound), [warning label](https://alert.psychnews.org/tag/warning-label) ## Related Posts [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/semaglutides_iStock-2025837738-Jun-24-2025-05-08-21-2835-PM.jpg?height=200&name=semaglutides_iStock-2025837738-Jun-24-2025-05-08-21-2835-PM.jpg) ](https://alert.psychnews.org/2024/10/semaglutide-linked-to-lower-risk-of.html) ## [Semaglutide Linked to Lower Risk of Alzheimer’s Disease in Type 2 Diabetes](https://alert.psychnews.org/2024/10/semaglutide-linked-to-lower-risk-of.html) 10/25/24 12:00 AM [ Read more ](https://alert.psychnews.org/2024/10/semaglutide-linked-to-lower-risk-of.html) [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/glp1_pen_iStock-2270017167.jpg?height=200&name=glp1_pen_iStock-2270017167.jpg) ](https://alert.psychnews.org/patients-with-mood-disorders-increasingly-turn-to-glp-1ras) ## [Patients With Mood Disorders Increasingly Turn to GLP-1RAs](https://alert.psychnews.org/patients-with-mood-disorders-increasingly-turn-to-glp-1ras) 6/3/26 2:30 PM [ Read more ](https://alert.psychnews.org/patients-with-mood-disorders-increasingly-turn-to-glp-1ras) [![](https://alert.psychnews.org/hs-fs/hubfs/glp_1-iStock-2189405678.jpg?height=200&name=glp_1-iStock-2189405678.jpg) ](https://alert.psychnews.org/2025/06/researchers-look-to-unlock-glp-1-drugs.html) ## [Researchers Look to Unlock GLP-1 Drugs’ Potential in Psychiatry](https://alert.psychnews.org/2025/06/researchers-look-to-unlock-glp-1-drugs.html) 6/4/25 4:00 PM [ Read more ](https://alert.psychnews.org/2025/06/researchers-look-to-unlock-glp-1-drugs.html) ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Psychiatric News Alert", "url" : "https://alert.psychnews.org/author/psychiatric-news-alert" }, "dateModified" : "2026-01-15T19:47:49.821Z", "datePublished" : "2026-01-15T18:26:23.000Z", "headline" : "FDA Asks Companies to Remove Suicide Risk Warning From GLP-1 RA Labels", "image" : [ "https://alert.psychnews.org/hubfs/Imported_Blog_Media/glp_pens_iStock-2241146296.jpg" ], "mainEntityOfPage" : { "@id" : "https://alert.psychnews.org/fda-asks-companies-to-remove-suicide-risk-warning-from-glp-1-ra-labels", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://alert.psychnews.org/hubfs/PN-Blue-Box.jpg" } } } ```