The U.S. FDA on Tuesday requested Novo Nordisk (NVO) and Eli Lilly (LLY) to implement labeling changes for their blockbuster weight loss drugs to reflect that there is no increased risk of suicidal behavior or ideation linked to the GLP-1 drugs.
Specifically, the regulator has asked the companies to remove warnings about the potential suicidal behavior or ideation linked to Novo’s (NVO) Wegovy (semaglutide), Saxenda (liraglutide), and Lilly’s (LLY) Zepbound (tirzepatide).
The FDA noted that an analysis comprising data from more than 90 placebo-controlled medication trials didn’t link GLP-1s with an increased risk for suicidal behavior/ideation or other adverse psychiatric events such as anxiety.
Additionally, the versions of the above drugs approved for diabetes no longer carry warnings about such a risk, the agency said, adding “today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 medications.”