EU Regulators Confirm No Link Between GLP-1 Drugs and Suicidal Thoughts

1. The European Medicines Agency (EMA) has concluded a nine-month investigation and found no evidence linking GLP-1 drugs, such as Ozempic and Wegovy, to an increased risk of suicidal thoughts and self-injury.
2. This finding echoes the U.S. Food and Drug Administration's (FDA) preliminary review in January, which also found no causal relationship between GLP-1 drugs and suicidal thoughts or actions.
3. The EMA's review included drugs from Novo Nordisk, such as Wegovy and Ozempic, but not Eli Lilly's Zepbound and Mounjaro.
4. The investigation was initiated in July 2024 following reports of three cases of suicidal thoughts and self-injury in patients taking drugs containing liraglutide and semaglutide.
5. The EMA's analysis of data from a large U.S. study and other studies, including a Nature Medicine paper, did not support a direct association between semaglutide and suicidal thoughts.
6. The EMA's Pharmacovigilance Risk Assessment Committee analyzed medical records, clinical trials, post-marketing surveillance data, and other studies during the review.
7. GLP-1 drug makers are required to continue monitoring for any events of suicidal thoughts or actions.
8. The FDA labels for Wegovy and Zepbound, which are approved for obesity, already warn doctors to monitor patients for suicidal thoughts, while the labels for Ozempic and Mounjaro, which are approved for type 2 diabetes, do not contain that warning.