European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to minimise the risk of aspiration and pneumonia aspiration reported in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) who undergo surgery with general anaesthesia or deep sedation.
As part of their action, GLP-1 RAs slow down gastric emptying (emptying of the stomach) and there is a biologically plausible increased risk for aspiration in association with anaesthesia and deep sedation when taking these medicines. Delayed gastric emptying is already listed in the product information for the different GLP-1 RAs: dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide and tirzepatide.
The PRAC reviewed available data including case reports in EudraVigilance, scientific literature and clinical and non-clinical data submitted by the marketing authorisation holders for these medicines.
The committee could not establish a causal association between GLP-1 analogues and aspiration, but because of the known action of delayed gastric emptying and the presence of clinical trial cases and post marketing cases. PRAC considered that healthcare professionals and patients should be informed on this potential consequence of delayed gastric emptying.
Therefore, the PRAC has recommended that the risk of residual gastric content being present because of delayed gastric emptying should be considered before performing procedures with general anaesthesia or deep sedation. The product information of GLP-1 RAs will be updated accordingly, including a warning to patients that they should inform the doctor involved if they take these medicines and are scheduled to undergo surgery under anaesthesia or deep sedation.
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