The US Food and Drug Administration (FDA) has requested that pharma companies marketing glucagon-like peptide-1 receptor agonists (GLP-1RAs) no longer include warnings about a potential risk of suicide thoughts, after the agency completed a review.
The FDA said it is asking drug application holders to remove information regarding the risk of suicidal ideation and behaviour (SI/B) from the labelling of weight loss branded GLP-1RAs, which currently list SI/B as a warning.
Eli Lilly’s Zepbound (tirzepatide) and Novo Nordisk’s Wegovy (semaglutide) are affected by the change. Novo’s older GLP-1RA, Saxenda (liraglutide), will also have its label updated.
In July 2023, after receiving post-marketing reports of SI/B in patients taking GLP-1RA medications, the FDA initiated an investigation into whether there is an established link between the drugs and the psychiatric adverse events.
The FDA has since completed a meta-analysis of 91 clinical trials across GLP-1RA drug development that included 60,338 patients treated with the weight loss drugs. The agency also conducted a retrospective cohort study using administrative healthcare claims data. In its conclusion after a two-year review, the FDA stated that there was no relationship between the use of GLP-1 RAs and the occurrence of SI/B.
An Eli Lilly spokesperson told Pharmaceutical Technology: “We appreciate the FDA’s careful consideration of this important safety issue. Patient safety is Lilly’s top priority, and we will continue to work with the FDA on next steps to ensure that appropriate safety information is available to prescribers.
A Novo Nordisk spokesperson told Pharmaceutical Technology: “We are happy to see the FDA’s recommendation to remove the warning regarding the risk of suicidal ideation and behaviour from GLP-1RA labels that currently include such language…We prioritise patient safety and will continue to collaborate closely with the FDA and other regulatory authorities to monitor the safety of all our GLP-1RA medicines.”
The outcome of the FDA investigation follows a similar decision by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in September 2024. After its own evaluation, the MHRA found no links between the medication and suicidal, self-injurious thoughts or actions.
Global sales for Lilly’s Zepbound surged 185% in Q3 2025 to bring in $3.59bn, while sales for Wegovy also increased in Q3 to DKr20.35bn ($3.2bn).
The label update comes at a time of change in the obesity market. Dominated by subcutaneous administration over recent years, Novo won FDA approval for the first oral GLP-1RA indicated for weight loss in December 2025.
Speaking at J.P. Morgan Healthcare Conference, held in San Francisco from 12 to 15 January, new CEO of Novo Nordisk, Maziar Mike Doustdar, placed importance on the pill for reaching more patients in the weight loss arena.
