A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.
The FDA has asked Novo Nordisk and Eli Lilly to remove warnings about suicidal behavior and ideation from their GLP-1 products, an adjustment the agency says will help harmonize the messaging across the drugs in this class.
These changes will affect Novo’s blockbuster weight-loss therapy Wegovy, as well as its older GLP-1 drug Saxenda, according to the FDA’s announcement on Tuesday. Lilly’s Zepbound, also indicated for chronic weight management, is likewise covered by the FDA’s announcement.
In mid-2023, reports of suicidal ideation and behavior in patients taking GLP-1s prompted regulators around the world to look into such risk. The European Medicines Agency launched its probe in July that year, followed by the FDA in January 2024. These investigations ultimately found no causal connection between GLP-1s and suicidality.
However, the agencies’ analyses at the time were hindered by the small number of reported instances of suicidal thoughts and behaviors, resulting in what the FDA on Monday called “considerable uncertainty in the risk estimate.”
For more clarity on the matter, the agency conducted a meta-analysis of different GLP-1 trials, encompassing more than 90 studies and nearly 108,000 patients. Findings did not indicate a heightened risk of suicidality in patients on GLP-1s. The FDA also found no elevated risk of other psychiatric side effects, such as psychosis, irritability, anxiety or depression.
To bolster its analysis, the FDA also looked at healthcare claims data from its Sentinel System—a national electronic database that monitors the safety of approved products—to compare suicidality between GLP-1s and sodium-glucose cotransporter 2 inhibitors, a popular drug class for treating type 2 diabetes.
Similarly, this latter analysis, which covered nearly 2.25 million patients, did not show an excess risk of suicidal ideation and behavior in patients taking GLP-1s.
“We are happy to see the FDA’s recommendation to remove the warning regarding the risk of suicidal ideation and behavior from GLP-1 RA labels,” a spokesperson for Novo Nordisk told BioSpace in an email. “We stand behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when taken under the care of a licensed healthcare professional.”
BioSpace has reached out to Eli Lilly for comment.
