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Recently, the European Medicines Agency (EMA)’s drug safety committee, PRAC, evaluated and analysed the potential risk of side effects in individuals who have used the GLP-1 class of drugs. This follows reports last June that individuals in Iceland reported experiencing bouts of suicidal and/or self-harm thoughts, nausea, vomiting, etc.
The PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide – and suicidal and self-injurious thoughts and actions.
GLP-1 receptor agonists are used to treat type 2 diabetes and some are also authorised for weight management under certain conditions in adults who are obese or overweight. The review started in July 2023 and in November 2023 the committee requested additional data from the marketing authorisation holders for these medicines, namely Ozempic, Rybelsus, Wegovy, Victoza, Saxenda, Xultophy, Byetta, Bydureon, Lyxumia, Suliqua and Trulicity.
Additionally, the committee analysed the results of a recent study, based on a large database of electronic health records, which investigated the incidence of suicidal thoughts in patients with overweight and type 2 diabetes mellitus treated with semaglutide or other non-GLP-1 receptor agonist medicines for diabetes or overweight. The study found no causal association between the use of semaglutide and suicidal thoughts.
Another study was conducted by EMA, based on electronic health records, which examined the risk of suicide-related and self-injury-related events in people with type 2 diabetes mellitus. The results did not support a causal association between the use of GLP-1 receptor agonists and this risk.
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 marketing authorisation holders for these medicines will continue to monitor these events closely, including any new publications, as part of their pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs).