FDA Says No Evidence of Suicidal Ideation in Diabetes/Diet Drugs

After evaluating reports of suicidal thoughts or action in patients taking diabetes and weight loss drugs containing glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as Ozempic/Wegovy, Byetta, Trulicity and Rybelsus, the FDA says its preliminary evaluation has found no evidence of these adverse events.

The agency said that because the information provided was often limited and because these events can be influenced by other potential factors, “these reports did not demonstrate a clear relationship with the use of GLP-1 RAs” but that it could not “definitively rule out that a small risk may exist” and would continue to look into the issue.

The FDA reported that it used information gained from its FDA Adverse Event Reporting System as well as a meta-analysis of postmarketing findings from multiple clinical trials.

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