FDA finds no evidence that Ozempic, similar drugs cause suicidal thoughts in preliminary evaluation

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 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.