其 他 安 全 警 示
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| The United Kingdom: MHRA finds evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal and self-injurious thoughts and actions (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that following a thorough review, the MHRA has concluded that the available evidence does not establish a causal relationship between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal behaviour, suicidal ideation, self-injury and depression.
In July 2023, a new potential safety risk was identified associated with the GLP-1 receptor agonists exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide, and the risk of suicidal thoughts and self-harm following an initial review of post-marketing reports.
Safety reviews were carried out by the Market Authorisation Holders (MAHs) for the GLP-1 receptor agonists exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide to assess the potential risk. These reviews also looked at the risk of depression. This request was made in the interest of patient safety following reports of these side effects.
The MHRA evaluation of the United Kingdom post-marketing data aligned with the conclusions of a European regulatory review which analysed the data from several sources, including post-marketing data, clinical trial data, epidemiological studies and scientific literature.
The MHRA concludes that the available data does not support a causal association between GLP-1 receptor agonists and suicide, suicidal ideation, self-injury and depression, and therefore no updates to the product information is warranted at this time.
The MHRA will continue to closely monitor the risk of severe psychiatric reactions associated with these receptor agonists and will assess new data as it becomes available.
Please refer to the following website in MHRA for details:
http://www.gov.uk/government/news/mhra-finds-evidence-does-not-support-a-link-between-glucagon-like-peptide-1-glp-1-receptor-agonists-and-suicidal-and-self-injurious-thoughts-and-act
In Hong Kong, there are registered pharmaceutical products containing exenatide (1 product), lixisenatide (2 products), liraglutide (5 products), dulaglutide (4 products), and semaglutide (11 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reactions with regard to exenatide (2 cases), lixisenatide (1 case), liraglutide (1 case), dulaglutide (5 cases), and semaglutide (10 cases), but these cases were not related to suicidal and self-injurious thoughts and actions, or depression. Related news were previously issued by European Medicines Agency, Health Sciences Authority and the United States Food and Drug Administration, and were posted on the Drug Office website since 12 Jul 2023, with the latest update posted on 13 Apr 2024. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Thursday, Sep 5, 2024
Issued at HKT 15:30
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