In July, the European Medicines Agency began reviewing GLP-1 receptor agonists, including Ozempic, Saxenda and Wegovy, because of Icelandic patients reporting thoughts of suicide and self-harm. The U.S. has not launched a similar probe.
The FDA Adverse Event Reporting System — which documents millions of side effects reported by drugmakers, healthcare workers and consumers — has reported a small number of suicidal ideation and other psychiatric reactions. As of June 30, the database has recorded two cases of intentional self-injury, four suicides, six suicide attempts, eight depression suicidal and 59 suicidal ideation reports related to Ozempic.
Because these are self-reported, the FDA cannot confirm a connection. "The information on this website does not confirm a causal relationship between the drug product and the reported adverse events," according to a disclaimer on the database.
The European Medicines Agency's review is ongoing, and as of July 7, it had collected about 150 reports of possible cases of self-injury and suicidal thoughts. Regulatory agencies in the U.S. have not indicated an inquiry into the possible risk, and clinical trial data has not found an association between Ozempic and suicidal thoughts.
"The totality of available evidence — which includes clinical studies and data from real world-use — does not suggest an increased risk of suicide or self-injurious behavior with Ozempic," Novo Nordisk told NBC News. "In completed Ozempic clinical studies, no events of suicide or self-injury were reported in patients treated with Ozempic."