European Medicines Agency’s safety committee (PRAC) has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1) – exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide – and cancer of the thyroid (a small gland in the front and lower part of the neck which makes and releases hormones).
GLP-1 receptor agonists are used to treat type 2 diabetes and, in some cases, for the treatment of obesity and overweight under certain conditions. The PRAC began assessing this safety signal following the publication of a study1 suggesting that there might be an increased risk of thyroid cancers with the use of these medicines in patients with type 2 diabetes mellitus.
The committee reviewed evidence from the published literature, including observational studies (Bezin et al1, 2022; Alves et al2, 2012; Hu et al3, 2022; Bea et al4, 2023) as well as cumulative data submitted by the marketing authorisation holders (MAHs) which included non-clinical, clinical and post-marketing data. At present, the PRAC considers that no updates to the product information are warranted based on the available data.
The MAHs for liraglutide- (including Victoza, Saxenda, Xultophy), semaglutide- (including Ozempic, Rybelsus, Wegovy), exenatide- (including Bydureon, Byetta), dulaglutide- (i.e.Trulicity) and lixisenatide- (including Lyxumia, Suliqua) containing products should 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).
👉 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023 | European Medicines Agency (europa.eu)
