A European Union regulator found no evidence of a “causal” link between GLP-1 drugs — such as Ozempic and Wegovy — and suicidal thoughts.
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) announced the findings of their nine-month probe of the issue on Friday.
The PRAC first launched its investigation last July after it received reports from Iceland of two Ozempic and Saxenda users reporting suicidal thoughts. In addition, a separate Saxenda user reported having thoughts of self-harm.
In November, the committee requested date from the drug makers of various GLP-1s including Novo Nordisk’s Ozempic and Wegovy; and Eli Lilly’s Trulicity. Additionally, the committee analyzed health records, studies, clinical trials and post-marketing surveillance data.
The PRAC concluded that the available evidence does not support a causal association between between GLP-1s and “and suicidal and self-injurious thoughts and actions.” The committee also said that manufacturers did not need to update their products’ information with any new warnings, however.
The EMA’s announcement comes months after a preliminary review by the U.S. Food and Drug Administration (FDA) also found no link between these medications to suicidal thoughts or actions.
Still, the American agency warned that it could not “definitively rule out that a small risk may exist” and said it would continue looking into the issue.
The FDA and EMA’s reviews both cited a National Institutes of Health-funded study which found that patients taking semaglutide — the active ingredient in Ozempic and Wegovy — actually had a lower risk of suicidal thoughts than those who took other diabetes and anti-obesity medications.
Sales of these drugs have helped transformed pharmaceutical companies like Eli Lilly and Novo Nordisk into the most valuable pharmaceutical companies in the world. Skyrocketing demand for Novo Nordisk’s Wegovy and Ozempic alone helped boost Denmark’s GDP in 2023.