The U.S. Food and Drug Administration (FDA) has requested that Novo Nordisk and Eli Lilly remove warnings related to suicidal thoughts and behavior from the labels of their GLP-1 weight loss medications. This change is intended to standardize the information presented across drugs in this category.
The FDA’s decision affects several widely used medications, including Novo Nordisk's Wegovy and Saxenda, as well as Eli Lilly's Zepbound. These products are prescribed for chronic weight management.
In 2023, reports emerged about potential risks of suicidal ideation among patients using GLP-1 drugs. This led regulatory agencies, including the European Medicines Agency and later the FDA, to investigate these concerns. After reviewing available evidence, both agencies did not find a direct link between GLP-1 use and suicidality.
At the time of these investigations, there were few reported cases, which created uncertainty in assessing risk. To address this gap, the FDA conducted a meta-analysis covering more than 90 clinical trials with nearly 108,000 participants. The analysis found no increased risk of suicidal thoughts or other psychiatric side effects such as psychosis, irritability, anxiety, or depression in patients taking GLP-1 drugs.
Additionally, the FDA reviewed healthcare claims data from its Sentinel System—a national electronic resource that monitors product safety—comparing rates of suicidality between patients on GLP-1s and those using sodium-glucose cotransporter 2 inhibitors for type 2 diabetes. This study involved almost 2.25 million patients and also did not show an elevated risk of suicidal ideation or behavior associated with GLP-1 treatments.
A spokesperson for Novo Nordisk told BioSpace by email: “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. 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.
