Other safety alerts
|
| |
| European Union: GLP-1 receptor agonists: available evidence not supporting link with thyroid cancer |
| |
European Medicines Agency (EMA) announces that its safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), has 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 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 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, as well as cumulative data submitted by the marketing authorisation holders 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-october-2023
In Hong Kong, there are registered pharmaceutical products containing dulaglutide (4 products), exenatide (1 product), liraglutide (4 products), lixisenatide (2 products) and semaglutide (11 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reaction on dulaglutide (5 cases), exenatide (2 cases), liraglutide (1 case), lixisenatide (1 case) and semaglutide (3 cases), but these cases were not related to thyroid cancer. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Monday, Oct 30, 2023
Issued at HKT 16:00
|
| |
