The US Food and Drug Administration (FDA) announced on Thursday that a preliminary evaluation of reports suggesting suicidal thoughts or actions among individuals taking drugs such as Ozempic and Wegovy for type 2 diabetes and weight loss did not find evidence indicating a causal relationship. These drugs belong to the class of GLP-1 receptor agonists, and the FDA stated that detailed reviews of reports in its Adverse Event Reporting System and clinical trial results did not demonstrate a clear connection. However, the agency acknowledged the possibility of a small risk and continues to investigate the issue.
The FDA emphasized that patients should not discontinue GLP-1 drugs without consulting their healthcare providers and should report any experiences of depression, suicidal thoughts, or unusual changes in mood or behavior. Last week, the FDA announced its review of reports associating GLP-1 drugs with suicidal thoughts, along with an investigation into cases of aspiration and alopecia among individuals using these medicines.
The European Medicines Agency is also examining a potential link between GLP-1 receptor agonists and suicidal thoughts, with an ongoing investigation initiated in July based on around 150 reports. GLP-1 drugs work by mimicking the hormone GLP-1, affecting insulin secretion, feelings of fullness, and appetite. European regulators seek additional information from drug manufacturers, and while no conclusive association has been established, further clarification is needed.
In a recent large review of electronic health records in the US, GLP-1 drugs were found to carry a lower risk of patients experiencing suicidal thoughts compared to other medications used for diabetes and weight loss. The FDA plans to conduct a meta-analysis using data from clinical trials and real-world use to continue evaluating the safety of all GLP-1 drugs, sharing final conclusions and recommendations after completing the review or obtaining additional information. The prescribing information for GLP-1 drugs approved for weight loss already includes warnings about the risk of suicidal thoughts and actions based on reports associated with older medicines used for weight loss. Healthcare professionals are advised to monitor patients for signs of depression, suicidal thoughts, or unusual mood changes.