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The US Food and Drug Administration (FDA) recently addressed concerns regarding the potential association between drugs such as Ozempic and Wegovy, used for type 2 diabetes and weight loss, and reports of suicidal thoughts or actions. The agency did not find conclusive evidence linking GLP-1 receptor agonists (which include Ozempic and Wegovy) to suicidal effects. However, the FDA acknowledged the limitations of the available information and the possibility of a small risk.
Current Investigation
The FDA emphasized that it would continue its investigation. This is considering the relatively low number of people experiencing suicidal thoughts or actions in both the groups on the medicines and those on a placebo during clinical studies. Patients were cautioned against discontinuing GLP-1 drugs without consulting their healthcare providers. They were also advised to report any changes in mood or behavior. This announcement followed the FDA's earlier statement about reviewing reports of suicidal thoughts associated with GLP-1 drugs. They are also evaluating the need for regulatory action. The agency is also investigating cases of aspiration and hair loss among individuals using these medications.
European regulators are also exploring a potential link between GLP-1 receptor agonists and suicidal thoughts. An ongoing investigation of theirs was initiated in July. The FDA's evaluation includes a meta-analysis of data from clinical trials and real-world use, using health insurance claims and patient health records. The agency pledged to share final conclusions and recommendations once the review is complete or more information becomes available.
Future Research
A recent review of electronic health records from the US suggested that these drugs carried a lower risk of patients having suicidal thoughts. This was compared to other medications for diabetes and weight loss. The FDA underscored that prescribing drugs approved for weight loss already includes warnings about the risk of suicidal thoughts and actions based on reports associated with older medicines used or tested for weight loss. Healthcare professionals are advised to remain vigilant in monitoring patients for signs of depression, suicidal thoughts, or unusual mood changes.
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