2023-11-03 14:22:30
The Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) has concluded that the available data do not currently make it possible to establish a link between the taking of medicines in the GLP-1 analogue (glucagon) class -like peptide-1) and the occurrence of thyroid cancer. GLP-1 analogs are used to treat poorly controlled type 2 diabetes, as a complement to diet and exercise. Certain medications are authorized for the treatment of obesity and overweight under certain conditions. At the request of the ANSM, the PRAC began to evaluate this safety signal following the publication of a French study (Bezin et al.) suggesting that there may be an increased risk of thyroid cancers with the use of these medications in patients with type 2 diabetes. In the United States, the Food & Drug Administration (FDA) contraindicates these medicinal products in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia type 2 (MEN2), particularly due to animal data whose relevance in humans remains uncertain.
The PRAC reviewed data from the published literature, including other observational studies as well as cumulative data which includes non-clinical, clinical, and post-marketing data. To date, the PRAC considers that no update of the SPC (summary of product characteristics) and the leaflet is justified on the basis of the available data. The risk of thyroid cancer remains closely monitored pending new data.
In France, the products concerned are:
liraglutide (Victoza, Saxenda, Xultophy), semaglutide (Ozempic), exenatide (Bydureon, Byetta), dulaglutide (Trulicity).
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