The U.S. Food and Drug Administration (FDA) on Tuesday said its preliminary review has not found evidence that glucagon-like peptide-1 receptor agonists, commonly known as GLP-1 RAs, cause suicidal thoughts or actions.
Current prescribing information for GLP-1 drugs, including Eli Lilly and Co.’s (NYSE:LLY) and Novo Nordisk A/S‘ (NYSE:NVO) drugs, approved for weight management already includes warnings about suicidal thoughts and actions.
Though the agency on Tuesday said it continues to study the issue due to limited data and the seriousness of the concern.
In a safety update, the FDA said it reviewed reports submitted to the FDA Adverse Event Reporting System involving patients taking GLP-1 medicines for type 2 diabetes, beint overweight or obesity.
The agency noted that the information in many reports was incomplete and often influenced by other factors, making it difficult to establish a clear connection between the drugs and suicidal behavior.
The agency also examined data from clinical trials, including large outcome studies and observational research. According to the FDA, those reviews did not show an association between GLP-1 RA use and suicidal thoughts or actions.
However, the FDA said the number of reported events was small in both treatment and control groups, meaning a minor risk cannot be definitively ruled out.
To further evaluate safety, the FDA is conducting a meta-analysis across all GLP-1 RA clinical trials and reviewing postmarketing data through its Sentinel System, a large database that analyzes health insurance claims and patient records.
The agency said it will share final conclusions and recommendations once the review is complete or additional information becomes available.
The FDA emphasized that patients should not stop taking GLP-1 medications without consulting a health care professional, warning that discontinuation could worsen underlying conditions. Patients are encouraged to speak with their providers if they experience new or worsening depression, suicidal thoughts or unusual changes in mood or behavior.
The FDA said these warnings are consistent with labels for other weight-loss medications and are based on reports associated with older therapies in the category.
LLY, NVO Price Action: Eli Lilly stock is down 0.13% at $1,079.20, and Novo Nordisk stock is up 0.39% at $59.60 at publication on Tuesday.
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