FDA has requested removal of suicidal ideation and behaviour warnings from GLP-1 receptor agonist weight-loss drugs after comprehensive safety review found no causal link.
Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration (FDA) has updated its safety assessment of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), a class of medicines used for type 2 diabetes and for weight management. This follows both an earlier review of suicide-related reports and a more recent comprehensive evaluation.
Background and Ongoing Evaluation
GLP-1 receptor agonists work by mimicking the incretin hormone GLP-1, which helps regulate blood sugar and appetite. These drugs include agents such as semaglutide, liraglutide, and tirzepatide and are used across diabetes and obesity indications.
After reports of suicidal thoughts or actions in patients taking GLP-1 RAs, the FDA began evaluating the available safety data. An earlier safety communication released on January 11, 2024, stated that preliminary evaluation of reports from the FDA Adverse Event Reporting System (FAERS), clinical trial data, and observational studies did not demonstrate a causal link between GLP-1 RAs and suicidal thoughts or actions. However, the agency noted it could not fully rule out a small risk because of limited data in some reports, and it committed to continuing its review.
2026 Safety Communication and Labelling Change
On January 13, 2026, the FDA issued a Drug Safety Communication updating its conclusions:
Key findings of the FDA’s comprehensive review
A large meta-analysis of 91 placebo-controlled trials including over 107,000 patients found no increased risk of suicidal ideation or behaviour (SI/B) with GLP-1 RA use compared to placebo. The analysis also looked at related psychiatric adverse events such as anxiety, depression, irritability, and psychosis, with no signal of increased risk.
A retrospective cohort study using FDA Sentinel System data compared new users of GLP-1 RAs with users of another diabetes drug class (SGLT2 inhibitors). After adjusting for baseline characteristics, there was no increased risk of intentional self-harm among GLP-1 RA users.
Reviews of published observational and pooled studies likewise did not support a causal relationship between GLP-1 RAs and SI/B.
Based on this body of evidence, the FDA has requested that product labels for GLP-1 RAs with existing language on suicidal ideation and behaviour be amended to remove these specific warnings. The affected products are those approved for weight reduction in people with overweight or obesity, including:
- Saxenda (liraglutide)
- Wegovy (semaglutide)
- Zepbound (tirzepatide)
Other GLP-1 RAs approved to improve glycemic control in type 2 diabetes did not carry SI/B warnings previously, and this update aims to align labelling across the class.
What the FDA Recommends
Patients taking GLP-1 RAs should continue their medication as prescribed. The FDA still encourages patients and caregivers to discuss any concerns with their health care professionals, especially if they notice new or worsening depression, suicidal thoughts, or unusual behaviour changes. Health care providers should be prepared to talk with patients about the current safety findings and refer individuals to mental health support if needed.
Broader Context: Suicidal Ideation Risk Guidance
While the FDA’s current evidence does not support a causal link between GLP-1 RAs and suicidal thoughts or actions, regulators in other regions may frame risk differently based on post-marketing data. For example, the Therapeutic Goods Administration (TGA) in Australia recently noted that suicidal behaviour and ideation have been reported with GLP-1 RAs in their adverse event database and recommended monitoring for depression, suicidal thoughts, and mood changes when initiating or continuing therapy, especially in patients with a history of these conditions.
This difference highlights how post-market surveillance data can vary across populations and reporting systems. Clinicians should be aware of both local regulatory guidance and broader safety evidence when assessing psychiatric risks with any therapy.
References
Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity, 11 January 2024, https://www.fda.gov/media/175358/download
FDA Requests Removal of Suicidal Behaviour and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications, 13 January 2026, https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp
Australia’s TGA Updates Safety Warnings for GLP-1 Receptor Agonists and Tirzepatide: Suicidal Ideation Precautions and New Contraception Advice, 01 December 2025, https://pharmacally.com/australias-tga-updates-safety-warnings-for-glp-1-receptor-agonists-and-tirzepatide-suicidal-ideation-precautions-and-new-contraception-advice/
