Italian Medicines Agency Agenzia Italiana del Farmaco

Meeting highlights from PRAC 23-26 October 2023 - Meeting highlights from PRAC 23-26 October 2023

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Meeting highlights from PRAC 23-26 October 2023

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023 with new safety information for GLP-1 receptor agonists.

EMA’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 committee reviewed available evidence, included a recently published study which triggered the review, and considers that no updates to the product information are warranted.

The MAHs for these medicinal products should continue to monitor these events closely.


Published on: 27 October 2023

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