EMA Dispels Link Between GLP-1 Receptor Agonists and Suicidal Ideation Risk New
- The EMA has concluded, after a nine-month review, that there is no conclusive evidence linking popular GLP-1 receptor agonists, such as Wegovy and Ozempic, to an increased risk of suicidal thoughts and self-injury.
- The investigation included Novo Nordisk's drugs, like Wegovy, Ozempic, Rybelsus, Saxenda, and Eli Lilly's Zepbound and Mounjaro.
- The EMA analyzed data from a large U.S. study and found no direct association between the use of semaglutide and suicidal thoughts.
- The agency also conducted a separate study, which did not support a causal association between GLP-1 drugs and the risk of suicidal thoughts.
- The review encompassed additional data from clinical trials, post-marketing surveillance, and other studies, including a Nature Medicine paper that found a lower risk of suicidal ideation linked to GLP-1 drugs.
- The EMA's findings echo those of a previous FDA review, which also found no causal relationship between GLP-1 drugs and suicidal thoughts.
- The EMA has requested that marketing authorization holders continue to monitor these events and report any new evidence on this issue in their pharmacovigilance activities.
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