其 他 安 全 警 示
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| European Union: EMA statement on ongoing review of GLP-1 receptor agonists (English only) |
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European Medicines Agency (EMA) announces that its safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists, including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). These medicines are used for weight loss and for treating type 2 diabetes.
The review was triggered by the Icelandic medicines agency following reports of suicidal thoughts and self-injury in people using liraglutide and semaglutide medicines. So far authorities have retrieved and are analysing about 150 reports of possible cases of self-injury and suicidal thoughts.
Liraglutide and semaglutide medicines are widely used, with an exposure of over 20 million patient- years to date (one patient-year is the equivalent of one patient taking a medicine for one year). It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors.
The review is being carried out in the context of a signal procedure. A signal is information on a new adverse event that is potentially caused by a medicine or a new aspect of a known adverse event that warrants further investigation. The presence of a signal does not necessarily mean that a medicine caused the adverse event in question.
Suicidal behaviour is not currently listed as a side effect in the European Union product information for any GLP-1 receptor agonists.
The review of Ozempic, Saxenda and Wegovy started on 3 Jul 2023 and has now been extended to include other GLP-1 receptor agonists (dulaglutide, exenatide and lixisenatide). This review is expected to conclude in Nov 2023.
As with all medicines, patients and healthcare professionals are advised to use GLP-1 receptor agonists in accordance with the approved product information. Patients and healthcare professionals should also report suspected side effects to authorities.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-statement-ongoing-review-glp-1-receptor-agonists
In Hong Kong, there are registered pharmaceutical products containing dulaglutide (4 products), exenatide (1 product), liraglutide (3 products), lixisenatide (2 products) and semaglutide (6 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reaction related to dulaglutide (5 cases), exenatide (2 cases), liraglutide (1 case), lixisenatide (1 case) and semaglutide (2 cases), but these cases were not related to suicidal thoughts or self-injury. As the EMA’s 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/Wednesday, Jul 12, 2023
Issued at HKT 15:00
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