The European Medicines Agency’s (EMA) safety committee has concluded that the available evidence does not point to a causal link between glucagon-like peptide-1 (GLP-1) receptor agonists and thyroid cancer.
The EMA Pharmacovigilance Risk Assessment Committee (PRAC) reviewed data from published literature including observational studies and cumulative data from marketing authorisation holders. This included clinical, non-clinical and post-marketing data.
Following this, the agency decided that no updates to the product information were needed based on the available data.
However, the marketing authorisation holders for Victoza (liraglutide), Rybelsus (semaglutide), Byetta (exenatide), Trulicity (dulaglutide), and Suliqua (lixisenatide) will need to monitor events carefully, including any newly published data, as part of their pharmacovigilance responsibilities. Any new evidence would have to be reported in a periodic safety update report.
The committee began assessing the drugs following the release of the ‘GLP-1 Receptor Agonists and the Risk of Thyroid Cancer’ study in the 2022 Diabetes Care journal. The initial study analysed the French National Health Care Insurance Data System (SNDS) database and concluded that there was an increased risk of all thyroid cancer and medullary thyroid cancer with the use of GLP-1 receptor agonists. This was particularly seen after one to three years of use.
GLP-1 receptor agonists are developed for weight management and the treatment of type 2 diabetes. The agency approved its first GLP-1 receptor agonist, AstraZeneca’s Byetta in 2006. The EMA has since approved Novo Nordisk’s Saxenda (liraglutide) in 2017, otherwise known as Victoza, and Rybelsus in 2020, which is marketed as Ozempic and Wegovy in the US.
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The agency is also in the midst of a review, assessing the causal association between the drug class and the risk of suicidal thoughts and self-harm. The evaluation was triggered by the Icelandic medicines agency following reports of suicidal thoughts and self-injury in patients using liraglutide and semaglutide medicines.
The review first began with an analysis of Ozempic, Saxenda and Wegovy in July 2023, and extended to include other GLP1RAs. The EMA expects the review to conclude in November 2023.
