其 他 安 全 警 示
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| The United States: Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity: glucagon-like peptide-1 receptor agonists (English only) |
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The US Food and Drug Administration (FDA) announces that it has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists (GLP-1 RAs). These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. FDA’s preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions. FDA-approved GLP-1 RAs include exenatide, liraglutide, dulaglutide, lixisenatide, semaglutide and tirzepatide.
Over the last several months, FDA has conducted detailed reviews of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System. Because the information provided was often limited and because these events can be influenced by other potential factors, FDA determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs. Similarly, FDA’s reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions. However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, FDA cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue.
Additional evaluations include a meta-analysis of clinical trials across all GLP-1 RA products and an analysis of postmarketing data in the Sentinel System. A meta-analysis is a large, combined analysis of findings from clinical trials. Sentinel is a very large data network that contains health insurance claims and patient health records that can be used to investigate safety questions about FDA-regulated products. FDA will communicate the final conclusions and recommendations after FDA completes the review or has more information to share.
Patients should not stop taking GLP-1 RAs without first consulting their health care professional, as stopping these medicines may worsen their condition. Talk to their health care professional if they have questions or concerns. Tell their health care professional if they experience new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.
Health care professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior. Health care professionals should consult the prescribing information when treating patients with these medications.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type
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. There is no registered pharmaceutical product containing tirzepatide. 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 (3 cases), but these cases were not related to suicidal thoughts or actions. Related news was previously issued by European Medicines Agency and Singapore Health Sciences Authority, and was posted on the Drug Office website on 12 Jul 2023, 22 Sep 2023 and 2 Dec 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/Friday, Jan 12, 2024
Issued at HKT 14:30
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