The US Food and Drug Administration (FDA) has ordered pharmaceutical companies that sell GLP-1 receptor agonists to remove warnings about the possible risk of suicidal thoughts, after conducting a detailed analysis of the available data.
According to the FDA announcement, manufacturers of drugs for treating Type 2 Diabetes and obesity from the GLP-1 class should delete statements related to the risk of suicidal ideation and behavior from the official documentation and labeling of the drugs, since these risks were previously listed as warnings.
The change applies to Eli Lilly’s Zepbound (Tirzepatide) and Novo Nordisk’s Wegovy (Semaglutide), while the older GLP-1 agonist, Sexenda (Liraglutide), will also receive updated labeling. In July 2023, the FDA began a detailed review and investigation after post-marketing surveillance reports of suicidal thoughts and behavior in patients using GLP-1 agonists. The goal of the analysis was to determine whether there is a real association between the use of these drugs and psychiatric side effects.
During the two-year evaluation, the FDA conducted a comprehensive meta-analysis of 91 clinical trials in the development of GLP-1RA drugs, which included a total of 60.338 patients treated with these therapies for weight management. In addition, data from retrospective studies based on health administrative databases were analyzed.
Based on all the evidence gathered, the FDA has concluded that there is no evidence of an association between the use of GLP-1 agonists and the occurrence of suicidal ideation or behavior.
Regarding the decision, a spokesperson for Eli Lilly told Pharmaceutical Technology: “We welcome the FDA’s thorough assessment of this crucial safety issue. Patient safety is Lilly’s highest priority, and we will continue to work closely with regulatory authorities to ensure that healthcare professionals have clear and up-to-date information about the safety of therapy”.
A spokesperson for Novo Nordisk told Pharmaceutical Technology: “We are pleased that the FDA is recommending the removal of the warning about the risk of suicidal thoughts and behavior from the instructions for GLP-1RA drugs that previously contained such statements. Patient safety is our absolute priority, and we will continue to work closely with the FDA and other regulatory bodies to ensure the safety of all our GLP-1RA therapies.”
The FDA’s decision follows a similar assessment by the UK’s Medicines and Healthcare Products Agency (MHRA) in September 2024, which concluded that there was no link between the use of these drugs and suicidal or self-harming thoughts and behavior.
Global sales of Eli Lilly’s Zepbound grew 185% in the third quarter of 2025, reaching $3.59 billion, while revenues from Wegovy increased to DKK 20.35 billion (about $3.2 billion) in the same period.
The update to the instructions comes at the same time as significant changes in the market for drugs to treat obesity. While subcutaneous administration dominated in previous years, Novo Nordisk received FDA approval in December 2025 for the first oral GLP-1RA for weight loss, facilitating broader access to the therapy.
On J.P., at the Morgen Healthcare Conference in San Francisco (January 12-15), Novo Nordisk’s new CEO, Maziar Mike Doustdar, particularly emphasized the importance of an oral version of the drug to expand the availability of weight management therapy.
