The U.S. Food and Drug Administration ordered drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviors from their blockbuster GLP-1 weight-loss medications, the agency said Tuesday.
In a statement, the FDA said its comprehensive review “found no increased” risk related to suicide among users of GLP-1 drugs for obesity, including Novo Nordisk’s Wegovy and Saxenda and Eli Lilly’s Zepbound.
The FDA said it had previously conducted a preliminary review in January 2024, which it said showed no link between the drugs and suicidal thought or actions. At the time, the agency said it could not rule out that “a small risk may exist.”
The FDA said labeling for other GLP-1 receptor agonists approved to treat diabetes carried no such warnings.
“Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications,” FDA officials said.