Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medical records of patients in the United States shows no link between use of the GLP-1 drugs and an increase in suicidal thoughts.
In fact, the research, which was conducted by the Nature Journal and included 1.8 million diabetes and obesity patients, shows that those who were on semaglutide were less likely to have suicidal thoughts than patients on other diabetes and obesity treatments.
As demand has skyrocketed for the blood sugar-moderating drugs produced by Novo and Eli Lilly, they have come under increased scrutiny. In July of last year, the European Medicines Agency began investigating Ozempic and Wegovy after reports from Iceland of suicidal thoughts from two users and self-harm from another.
On Tuesday, the U.S. regulator revealed that it was looking into Novo’s semaglutide and Lilly’s tirzepatide based on reports of suicidal ideation, alopecia (hair loss) and aspiration that were gathered in the FDA Adverse Event Reporting System (FAERS) database.
“The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FDA wrote. “It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”
Through September of last year, the FDA had received 201 reports of suicidal thoughts from users of semaglutide or tirzepatide. Novo and Lilly’s drugs work similarly as GLP-1 agonists, while Lilly’s have a second action component as a GIP receptor agonist.
In the Nature study, which was funded by the National Institutes of Health, researchers found that first-time suicidal thoughts were reported by 0.11% of patients on Wegovy compared to 0.43% of patients on other weight loss treatments.
Similar results were seen comparing patients on Ozempic versus those on other type 2 diabetes drugs. The research included 1.6 million diabetes patients and 240,000 taking obesity drugs.