FDA Releases Preliminary Evaluation: No Evidence Linking Ozempic and Similar Drugs to Suicidal Thoughts

The US Food and Drug Administration announced on Thursday that its initial assessment of reports of suicidal thoughts or actions in individuals taking drugs such as Ozempic and Wegovy for type 2 diabetes and weight loss has not shown evidence that these drugs cause such effects. The agency stated that after conducting thorough reviews of reports received in its FDA Adverse Event Reporting System (FAERS) over the past few months, it found that the limited nature of the information and the potential influence of other factors did not establish a definitive link between the use of GLP-1 receptor agonists and these events.

GLP-1 receptor agonists such as Ozempic, Wegovy, Mounjaro, and Zepbound are a class of drugs. The FDA reviewed clinical trial results and did not find an association with suicidal thoughts or actions, but noted that it couldn't rule out a "small risk" due to the low number of cases. The investigation into this issue is ongoing.

Rebekah Carl injects herself with her weekly dose of Wegovy in New Columbia, Pennsylvania, U.S., November 13, 2023. REUTERS/Hannah Beier

Hannah Beier/Reuters

Ozempic, Wegovy not associated with higher risk of suicidal ideation in large review of US health records

Patients are advised to consult their health-care providers before discontinuing GLP-1 drugs and to inform them if they encounter depression, suicidal thoughts, or any unusual changes in mood or behavior, according to the FDA.

The agency recently announced that it is investigating reports of individuals experiencing suicidal thoughts while using GLP-1 drugs and assessing whether regulatory action is necessary. Additionally, the FDA is examining cases of aspiration and alopecia (hair loss) in individuals using these medications.

The FDA's investigation coincided with European regulators' probe into potential associations between the medications and suicidal ideation. In July, the European Medicines Agency launched an inquiry after receiving approximately 150 reports of potential incidents of self-harm and suicidal thoughts in individuals using GLP-1 receptor agonists.

These drugs function by emulating GLP-1, a hormone that impacts insulin secretion, satiety, and hunger. Scientists have observed that GLP-1 also influences the brain.

The European review is still in progress, with the agency stating in December that its Pharmacovigilance Risk Assessment Committee was requesting additional information from the manufacturers. The agency also noted that while no definitive conclusion has been reached regarding a causal association, there are several unresolved issues.

Recently, a comprehensive review of electronic health records in the US revealed that GLP-1 drugs have a lower risk of causing patients to have suicidal thoughts compared to other medications used for diabetes and weight loss.

Sign up for CNN Health's weekly newsletter to stay updated on the latest health news and insights.

Register here to receive The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

On Thursday, the FDA announced plans to conduct a comprehensive safety evaluation of all GLP-1 drugs using a "meta-analysis" of data from clinical trials and real-world use, including health insurance claims and patient health records. The FDA stated that it will provide "final conclusions and recommendations" once the review is completed or as more information becomes available.

The agency stated that the prescribing information for GLP-1 drugs approved for weight loss includes warnings about the potential risk of suicidal thoughts and actions. This is based on reports of such events being observed with a variety of older medicines used or tested for weight loss. The agency emphasized that healthcare professionals should continue to monitor patients for signs of depression, suicidal thoughts, or any unusual mood changes.