FDA removes warning labels from GLP-1 weight-loss drugs
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, reports BritPanorama.
This request, also covering Novo’s older weight-loss drug Saxenda, follows a review by the U.S. Food and Drug Administration (FDA) which found no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior.
Originally developed to treat type 2 diabetes, GLP-1 receptor agonists mimic a gut hormone that suppresses appetite, creating a feeling of fullness.
The FDA had previously reached a similar conclusion following a preliminary review in 2024, acknowledging at that time that it could not rule out a small risk due to limited data.
On Tuesday, the regulator stated 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 compared to placebo, nor of other psychiatric side effects like anxiety, depression, irritability, or psychosis.
The review encompassed 91 trials involving 107,910 patients, including 60,338 who received a GLP-1 drug and 47,572 who were given a placebo, it reported.
Eli Lilly and Novo Nordisk did not immediately respond to requests for comment.
