No ‘clear relationship’ between drugs like Ozempic and suicidal thoughts in preliminary FDA review

Despite receiving reports of patients experiencing suicidal ideation last year, the Food and Drug Administration (FDA) said it has not found a link between this side effect and the class of diabetes drugs that includes Ozempic, Mounjaro and Zepbound.

The FDA received reports in 2023 of patients experiencing suicidal ideation, hair loss and aspiration — an obstruction of the airway — after taking GLP-1 agonists, a category of drugs that treats diabetes and obesity by mimicking a naturally-occurring hormone.

These side effects were not listed on the medication guides for popular GLP-1 agonists, leading the FDA to open an inquiry into whether further regulation was needed for these types of drugs.

“Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” the FDA said in a Thursday statement.

“Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs,” said the agency.

“Similarly, our reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”

A recently published NIH-funded study found that semaglutide — a GLP-1 agonist marketed under the names Ozempic, Rybelsus and Wegovy — actually had a lower risk of suicidal ideation when compared to other diabetes and obesity treatments.

Due to the small number of people reporting suicidal thoughts in both groups taking GLP-1 agonists and control groups, however, the FDA said it could not “definitively rule out” a small risk from taking these types of drugs.

Final conclusions and recommendations will be shared once the FDA has completed its review. The agency advised that patients “should not stop taking GLP-1 RAs without first consulting your health care professional, as stopping these medicines may worsen your condition.”

GLP-1 agonist makers have stood by their products amid the speculation. Novo Nordisk, the exclusive manufacturer of semaglutide drugs, said it “stands behind the safety and efficacy” of all their GLP-1 agonist drugs when they’re taken as indicated and under supervision of a licensed health care professional.

Eli Lilly, the maker of the GLP-1 agonist Mounjaro, said it was “collaborating with the FDA on these potential signals,” while also emphasizing that its drugs are always being monitored following “rigorous study for many years in clinical trials and a robust approval process.”