EU probe finds no added suicide risk linked to GLP-1 agonists

12 Apr 2024
firstwordpharma.com
Drug ApprovalClinical Result
The European Medicines Agency (EMA) announced on Friday that it found no added risk of suicidal and self-injurious thoughts associated with GLP-1 receptor agonistsGLP-1 receptor agonists, including the ones sold by Novo Nordisk and Eli Lilly.
"After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies," the EMA said that "no update to the product information is warranted." The drugmakers will continue to monitor these events as part of their pharmacovigilance activities and "report any new evidence on this issue."
The review started last July after it was reported that some patients using liraglutide and semaglutide experienced thoughts of suicide or self-injury. (For more, see Spotlight On: Heavy burden of obesity likely a factor in suicidal ideation signals, experts say). In November, the EMA widened its investigation, requesting additional data from the makers of Ozempic (semaglutide), Wegovy (semaglutide), Rybelsus (semaglutide),  Victoza (liraglutide), Saxenda (liraglutide), Xultophy (degludec/liraglutide), Byetta (exenatide), Bydureon (exenatide), Lyxumia (lixisenatide), Suliqua (glargine/lixisenatid), and Trulicity (dulaglutide).
Additionally, the EMA said it analysed the results of an electronic health records study, published in Nature Medicine in January, which investigated the incidence of suicidal thoughts in nearly 241,000 patients with overweight and type 2 diabetes treated with semaglutide or other non-GLP-1 receptor agonistsnon-GLP-1 receptor agonists. The study found no causal association between the use of semaglutide and suicidal thoughts. Another recent electronic health records study, conducted by EMA, did not support a causal association between the use of GLP-1 receptor agonists and this risk of suicide-related and self-injury-related events in people with type 2 diabetes.
In January, a preliminary FDA report found no link between GLP-1 receptor agonists and suicidal thoughts or actions.
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