The U.S. health regulator on Tuesday asked drugmakers to remove label warnings about a potential risk of suicidal thoughts from widely used GLP-1 weight-loss drugs, including Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.
The request, also covering Novo’s older weight-loss drug Saxenda, follows a review by the U.S. Food and Drug Administration that found no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior.
GLP-1 receptor agonists were originally developed to treat type 2 diabetes. They mimic a gut hormone that suppresses appetite, creating a feeling of fullness.
The FDA had reached similar conclusion following a preliminary review in 2024, but had acknowledged at the time that it could not rule out a small risk because of limited data.
The regulator said on Tuesday it had conducted further analyses of placebo-controlled clinical trials involving GLP-1 drugs, which did not show an increased risk of suicidal thoughts or behavior versus placebo, or of other psychiatric side effects such as anxiety, depression, irritability or psychosis.
The review covered 91 trials involving 107,910 patients, including 60,338 who received a GLP-1 drug and 47,572 who received placebo, it said.
Eli Lilly and Novo Nordisk did not immediately respond to Reuters’ requests for comment.
