The US Food and Drug Administration said Thursday that a preliminary evaluation of reports of suicidal thoughts or actions among people taking drugs like Ozempic and Wegovy for type 2 diabetes and weight loss has not found evidence that the drugs cause those effects.
The agency said in a statement that it conducted “detailed reviews” over the last several months of reports received in its FDA Adverse Event Reporting System, or FAERS. It noted that because “the information was often limited and because these events can be influenced by other factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 (receptor agonists).”
GLP-1 receptor agonists are the class of drugs that includes Ozempic and Wegovy, as well as Mounjaro and Zepbound.
The FDA also said it reviewed clinical trial results and didn’t find an association. But it noted it couldn’t rule out a “small risk,” since there were so few people who experienced suicidal thoughts or actions in the studies — in both the groups on the medicines and those on placebo — so it said it’s continuing to investigate the issue.
Patients should not stop taking GLP-1 drugs without consulting with their health-care providers, and should tell them if they experience depression, suicidal thoughts or any unusual changes in mood or behavior, the FDA said.
The agency said last week that it was reviewing reports of people experiencing suicidal thoughts while taking GLP-1 drugs, and evaluating the need for regulatory action. In the same report, the agency said it was also looking into cases of aspiration and alopecia, or hair loss, among people on the medicines.
The FDA’s review came as European regulators are also looking into a potential link between the medicines and suicidal thoughts. The European Medicines Agency opened an investigation in July after it received about 150 reports of possible cases of self-injury and suicidal thoughts among people taking GLP-1 receptor agonists.
The medicines work by mimicking a hormone, GLP-1, that affects insulin secretion, feelings of fullness and appetite. Researchers have noted that GLP-1 also has an effect on the brain.
The European review is ongoing; the agency said in December that its Pharmacovigilance Risk Assessment Committee was seeking more information from the drugs’ makers, and that “while at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified.”
Late last week, a large review of electronic health records from the US found that GLP-1 drugs actually carried a lower risk of patients having suicidal thoughts compared with other medicines that work in different ways for diabetes and weight loss.
Dr. Rong Xu of Case Western Reserve University School of Medicine, who helped run the study, told CNN the reports US and European regulators were looking into “are case reports … to derive a conclusion, you really need to perform a head-to-head comparison between similar patients.”
The FDA said Thursday that it would also use a “meta-analysis” of data from clinical trials and real-world use, through health insurance claims and patient health records, of all GLP-1 drugs to continue to evaluate their safety. It said it would share “final conclusions and recommendations” after it finishes the review or has more information.
The agency noted the prescribing information for GLP-1 drugs approved for weight loss includes warnings about the risk for suicidal thoughts and actions. It said that’s based on reports of those events “observed with a variety of older medicines used or tested for weight loss.”
The agency said health-care professionals should still monitor patients for suicidal thoughts, signs of depression or any unusual mood changes.
