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| United Kingdom: GLP-1 and dual GIP/GLP-1 receptor agonists: potential risk of pulmonary aspiration during general anaesthesia or deep sedation (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Healthcare professionals should be aware of the potential risk of pulmonary aspiration in patients using GLP-1 or dual GIP/GLP-1 receptor agonists who undergo surgery or procedures with general anaesthesia or deep sedation.
GLP-1 and dual GIP/GLP-1 receptor agonists are a class of medications that are used to treat type II diabetes mellitus and/or obesity. The GLP-1 and dual GIP/GLP-1 receptor agonists available in the UK include dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide. Tirzepatide is a GLP-1 receptor agonist combined with glucose-dependent insulinotropic polypeptide (GIP) receptor agonist. Semaglutide is also approved to reduce the risk of cardiovascular events in patients with established cardiovascular disease.
Residual gastric content is a risk factor for aspiration in patients who undergo surgery or procedures with general anaesthesia or deep sedation. All GLP-1 and dual GIP/GLP-1 receptor agonists slow down gastric emptying, therefore patients taking these medicines may have a higher risk of pulmonary aspiration due to retained gastric contents. This can potentially lead to severe complications, such as aspiration pneumonia. Cases have been reported in the literature as well as through Yellow Card reports.
A recent European review of the available evidence for all GLP-1 and dual GIP/GLP-1 receptor agonists concluded that the data supports an association between GLP-1 or dual GIP/GLP-1 receptor agonists and the potential risk of pulmonary aspiration during anaesthesia or deep sedation because of the delayed gastric emptying associated with these medicines. The findings of this review were considered by the Pharmacovigilance Expert Advisory Committee (PEAG) of the Commission on Human Medicines (CHM), which agreed with the recommendations. The product information of all GLP-1 and dual GIP/GLP-1 receptor agonists has been updated to include the potential risk of pulmonary aspiration under general anaesthesia or deep sedation.
The PEAG recommended that the MHRA inform healthcare professionals and patients of the possibility of aspiration in patients using GLP-1 or dual GIP/GLP-1 receptor agonists who undergo surgery or procedures requiring general anaesthesia or deep sedation.
The European assessment evaluated whether a specific time to pause the use of a GLP-1 or dual GIP/GLP-1 receptor agonist prior to anaesthesia could be recommended, as well recommending new fasting guidelines or an appropriate medical procedure to confirm an empty stomach. The evidence to support further recommendations was limited and it was concluded that anaesthetists should retain the flexibility to provide individualised assessment.
New warnings have been added to the Summaries of Product Characteristics (SmPC) and Patient Information Leaflets. The new advice aims to raise awareness of the risk of pulmonary aspiration amongst healthcare professionals and patients. Anaesthetists are warned that residual gastric contents may remain despite routine recommended fasting in patients taking a GLP-1 or dual GIP/GLP-1 receptor agonists. This should be considered within the preoperative risk assessment, with subsequent management in preventing or minimising the risk.
Please refer to the following website in MHRA for details:http://www.gov.uk/drug-safety-update/glp-1-and-dual-gip-slash-glp-1-receptor-agonists-potential-risk-of-pulmonary-aspiration-during-general-anaesthesia-or-deep-sedation
In Hong Kong, there are registered pharmaceutical products containing dulaglutide (4 products), exenatide (1 product), liraglutide (5 products), lixisenatide (2 products), semaglutide (11 products), and tirzepatide (6 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reactions with semaglutide (10 cases; of which 3 were related to aspiration pneumonia). The DH has also received adverse drug reactions with dulaglutide (5 cases), exenatide (2 cases), liraglutide (1 case) and lixisenatide (1 case), but these cases were not related to aspiration and pneumonia aspiration. The DH has not received any case of adverse drug reaction related to tirzepatide. Related news was previously issued by the European Medicines Agency (EMA), and was posted on the Drug Office website on 13 Jul 2024. Letters to inform local healthcare professionals was issued on 15 Jul 2024. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, February 1, 2025
Issued at HKT 14:00
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