The US Food & Drug Administration (FDA) has asked Novo Nordisk and Eli Lilly to remove warnings about suicidal ideation or behaviour from the labels of their GLP-1 weight loss drugs.
Endpoints News reports that Novo’s Saxenda and Wegovy, as well as Lilly’s Zepbound, were singled out for label updates after “a comprehensive FDA review” that found no increased risk of such suicidal tendencies.
The agency said this week that it wants to “ensure consistent messaging,” as labels on other GLP-1s that were approved to improve blood sugar control or diabetes complications don’t currently describe a risk of SI/B.
Clinical trial data found no association between the use of GLP-1s and suicidal thoughts and actions, the FDA said, while noting a few instances were observed in individual trials.
Its comprehensive meta-analysis of 91 placebo-controlled clinical trials across GLP-1 development programmes “did not show an increased risk for SI/B or for other relevant psychiatric adverse events such as anxiety, depression, irritability, or psychosis”, and its review “does not support a causal relationship between the use of GLP-1 RAs and the occurrence of SI/B”.
Preliminary evidence shared in January 2024 made a similar case, noting that internal reviews, at the time, of large outcome studies and observational studies did not link GLP-1s and the occurrence of suicidal thoughts or actions.
Novo and Lilly didn’t immediately provide comment.
See more from MedicalBrief archives:
GLP-1 receptor agonists not linked to suicide – UK cohort study
Questions remain on weight loss drugs’ suicide risk – US study
European agency probes weight loss drugs’ link to suicidal thoughts