FDA: No Link Between Ozempic, Wegovy and Suicidal Thoughts
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New information from the U.S. Food and Drug Administration suggests that common weight loss medications Ozempic and Wegovy might not be linked to thoughts of self-harm as originally suspected.
The FDA announced the preliminary results of its review only nine days after initially announcing it would investigate the potential connection in a drug safety report dated Jan. 2, 2024. The report indicated that the agency was “evaluating the need for regulatory action” for Ozempic, Wegovy and related drugs after receiving more than 130 adverse event reports of suicidal ideation or thoughts among people taking the drugs.
Days later, the National Institutes of Health published a separate analysis of 1.8 million electronic health records indicating people taking the drugs had lower incidents of suicidal thoughts than the general population.
Quick Turnaround From FDA
It was just over a week between the initial announcement that the FDA was evaluating the need for new action and the Agency’s announcement that it found no evidence of a link between the weight loss drugs and suicidal ideation.
Timeline of Ozempic, Wegovy Suicidal Thoughts Findings Announcements
- Jan. 2, 2024: In announcing the evaluation of further regulatory reform, the FDA said, “[W]e determined that the information in these reports did not demonstrate a clear relationship with the use of [drugs in Wegovy’s and Ozempic’s class].”
- Jan. 5, 2024: In a separate study published in the journal Nature Medicine, researchers said, “Our findings do not support higher risks of suicidal ideation with semaglutide [Ozempic and Wegovy] compared with non-GLP1R agonist anti-obesity or anti-diabetes medications.”
- Jan. 11, 2024: The FDA released a Drug Safety Communication stating, “Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.”
The FDA emphasized the finding was only preliminary and that the agency is still evaluating the drugs’ suicidal ideation risk.
Study: Ozempic Users Had Lower Suicidal Thoughts Risk
In the study involving over 100 million individuals, NIH researchers explored the potential link between suicidal thoughts and prescription drugs Wegovy and Ozempic. Using anonymized health records, they studied two groups: more than 240,000 taking Wegovy or similar weight loss drugs and almost 1.6 million taking Ozempic or other blood sugar medications, monitoring suicidal thoughts as part of routine health checks.
“Our findings do not support higher risks of suicidal ideation with semaglutide compared with non-GLP1R agonist anti-obesity or anti-diabetes medications,” the researchers said in Nature Medicine.
Comparisons revealed the incidence of suicidal thoughts in drug users versus those on alternative medications. The study also investigated the recurrence of suicidal thoughts in drug users with a history of such thoughts. The extensive database allowed detailed analyses by sex, race and age.
The researchers found people taking the drugs were slightly less likely than those not taking them to have suicidal thoughts.
FDA Continues To Monitor Ozempic, Wegovy for Suicidal Thoughts
Though the FDA’s preliminary evaluation found no link to suicidal thoughts, it continues to monitor Ozempic and Wegovy. In a statement, the Agency said the number of suicidal thoughts from people taking the drugs vs. the comparative control group was too small to be conclusive.
The data came from adverse event reports people sent to the FDA Adverse Events Reporting System (FAERS) database.
“[W]e cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue,” the Agency said in its Drug Safety Communication.
The European Medicines Agency, the European Union’s counterpart to the FDA, has also been investigating suicidal thoughts linked to Ozempic and Wegovy since July 2023. Like the FDA, the EMA opened its review after reports of possible adverse reactions to the drugs.
In a statement from that time, the EMA noted, “It is not yet clear whether the reported cases are linked to the medicines themselves or to the patient’s underlying conditions or other factors.”