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Federal regulators on Tuesday told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviors from their blockbuster weight-loss medications.
The U.S. Food and Drug Administration said a comprehensive review “found no increased” risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk’s Wegovy and Saxenda and Eli Lilly’s Zepbound.
A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that “a small risk may exist.” The new analysis puts those concerns to rest.
Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted.
“Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications,” officials said.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Federal regulators on Tuesday told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviors from their blockbuster weight-loss medications.
The U.S. Food and Drug Administration said a comprehensive review “found no increased” risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk’s Wegovy and Saxenda and Eli Lilly’s Zepbound.
A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that “a small risk may exist.” The new analysis puts those concerns to rest.
Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted.
“Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications,” officials said.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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