The European Medicines Agency found no link between semaglutide use and suicidal thoughts or actions, concluding a monthslong probe that followed an inquiry by the FDA that led to a similar conclusion last year.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began looking last July into reports of patients taking GLP-1s experiencing suicidal thoughts. After examining several studies based on patient health records, the group concluded that there was no need for the manufacturers to take action on their safety labeling.
The EMA said that the drugmakers would continue to monitor reports of suicidal thoughts and actions moving forward.
Novo Nordisk, which manufactures semaglutide under the brand name Ozempic for diabetes and Wegovy for obesity, told Endpoints News that the available evidence does not support a causal association.
“Novo Nordisk will continue to monitor reports of adverse drug reactions, including suicide and suicidal ideation, through routine pharmacovigilance,” a spokesperson said in an email.
The probe examined data on Novo Nordisk’s drugs containing semaglutide. It also looked into several older type 2 diabetes drugs, including Amylin and Eli Lilly’s Byetta and AstraZeneca’s Bydureon.
“After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies the PRAC considers that no update to the product information is warranted,” the EMA wrote.
The FDA looked into whether the drugs carried a risk of suicide and self-harm and concluded in a preliminary review in January that there was not a causal link. Further, an NIH-funded study, also published in January, found GLP-1s were actually associated with a lower risk of suicidal thoughts compared with other obesity and type 2 diabetes treatments.
The EMA panel did not look at Eli Lilly’s GLP-1, which it markets as Mounjaro for diabetes and Zepbound for obesity.