The U.S. Food and Drug Administration on Tuesday directed Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviors from their blockbuster weight-loss medications, saying a comprehensive review found no elevated risk.
The FDA said its review “found no increased” risk of suicide among users of GLP-1 receptor agonist drugs approved to treat obesity. The affected medications include Novo Nordisk’s Wegovy and Saxenda and Eli Lilly’s Zepbound.
The action resolved a question that had remained open since January 2024, when a preliminary FDA review found no link between the drugs and suicidal thoughts or actions but said officials could not rule out that “a small risk may exist.” The new analysis put those concerns to rest, the agency said.
The FDA noted that GLP-1 receptor agonists approved to treat diabetes carried no comparable warnings. Tuesday’s directive brought obesity-drug labeling in line with those products.
“Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications,” agency officials said.