The regulator found no evidence of a link between cancer and the use of Ozempic and GLP-1 agonists

The European Medicines Agency (EMA) has found no association between the use of glucagon-like peptide-1 (GLP-1) agonist drugs and thyroid cancer.

The European Regulatory Authority’s Pharmacovigilance Committee (PRAC EMA) reported that available data do not support an association between the use of GLP-1 agonists and an increased risk of thyroid cancer. The information is posted on the regulator’s website.

There is no need to enter data into the drug instructions or update product information. However, the regulator asks that it continue to closely monitor the information and report any new evidence on this issue.

The PRAC EMA assessed dulaglutide, lixisenatide, liraglutide, exenatide and semaglutide, which are recommended for the treatment of type 2 diabetes and obesity. Semaglutide is the active ingredient in Ozempic and Wegovy.

Evaluation of the possible link began following the publication of an article with data from the French National Health Insurance System (SNDS) registry that indicated a possible increased risk of cancer with exposure to GLP-1 agonists.

The relevant committee assessed published studies and also requested data from preclinical, clinical and post-registration studies from holders of drug registration certificates. Data assessment began in April 2023 after review of the new signal at a committee meeting.

In addition to this risk, the relevant committee of the European regulator continues to evaluate the relationship between the use of GLP-1 agonists and the occurrence of suicidal thoughts and thoughts of self-harm. The assessment was initiated by the Icelandic Medicines Agency after receiving reports of 150 possible cases. The procedure began in July 2023 and is scheduled for completion in November.

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