During its November 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 (GLP-1) receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer.
The PRAC concluded that the available evidence does not support a causal association between the GLP-1 receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer (the thyroid is a small gland in the front and lower part of the neck which makes and releases hormones).
Of note, GLP-1 is an intestinal hormone that ensures glycemic control.
The above-mentioned medicines “GLP-1 receptor agonists” are used to treat type 2 diabetes and, in some cases, for the treatment of obesity under certain conditions. The PRAC began assessing this safety signal following the publication of a study 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 al, 2022; Alves et al, 2012: Hu et al, 2022; Bea et al, 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, semaglutide, exenatide, dulaglutide and lixisenatide containing products should continue to monitor these events closely, including any new publications, as part of their routine pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs).
In Belgium, analogues of the incretin hormone GLP-1 are authorized and marketed under the following names:
- medicines with the active substance liraglutide: Victoza;
- medicines with the active substance exenatide: Bydureon;
- medicines with the active substance dulaglutide: Trulicity;
- medicines with the active substance semaglutide: Ozempic and Rybelsus.
More information is available on the EMA website.