Other safety alerts
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| European Union: GLP-1 receptor agonists’ review: PRAC requests further clarifications from marketing authorisation holders |
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European Medicines Agency (EMA) announces that its safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), has reviewed the available evidence from clinical trials, post-marketing surveillance and the published literature on reported cases of suicidal thoughts and thoughts of self-harm with medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide). While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified. The committee has agreed further lists of questions to be addressed by the respective marketing authorisation holders for these medicines, namely Ozempic, Rybelsus, Wegovy, Victoza, Saxenda, Xultophy, Byetta, Bydureon, Lyxumia, Suliqua and Trulicity.
The PRAC will rediscuss this topic at its meeting in April 2024. EMA will communicate further when new information is available.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-november-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 with dulaglutide (5 cases), exenatide (2 cases), liraglutide (1 case), lixisenatide (1 case) and semaglutide (3 cases), but these cases were not related to suicidal thoughts or self-injury. Related news was previously issued by European Medicines Agency and Health Sciences Authority, and was posted on the Drug Office website on 12 Jul 2023 and 22 Sep 2023. As the safety review is ongoing, the DH will remain vigilant on the conclusion of the review and safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/ Saturday, December 2, 2023
Issued at HKT 12:00
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