Following a preliminary review, the U.S. Food and Drug Administration found no evidence that weight-loss drugs cause suicidal thoughts.
What To Know: Following reports of suicidal thoughts or actions, the FDA conducted a review of a class of popular weight-loss and diabetes drugs known as GLP-1 RAs, which includes Novo Nordisk’s NVO Wegovy and Ozempic and Eli Lilly and Company’s LLY Zepbound.
The FDA released an update on Thursday stating that its preliminary review did not show definitive evidence that the drugs cause suicidal thoughts or actions.
“However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue,” the FDA said in a news release.
The European Medicines Agency is also conducting its own investigation into semaglutide, the active ingredient in Wegovy and Ozempic, after suicidal thoughts were reported by patients. The European regulator requested more information from Novo Nordisk in December.
The FDA explained that current prescribing information for the GLP-1 RAs approved to treat patients with obesity contains information about the risk of suicidal thoughts and actions and is based on reports of such events observed with some older medicines used for weight loss.
The agency also noted that free support is available 24 hours a day, seven days a week via call or text to 988 or at 988lifeline.org.
The FDA said it will release its final conclusions and recommendations after its review of the GLP-1 RAs is complete.
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