PRAC elects new chair
The July 2024 meeting of EMA’s safety committee (PRAC) was the last plenary meeting chaired by Sabine Straus, who retires as Chair after serving for two three-year mandates. The Committee elected Ulla Wändel Liminga from Sweden as its new Chair.
New recommendations for GLP-1 receptor agonists to minimise risk of aspiration and pneumonia aspiration during general anaesthesia or deep sedation
Patients treated with GLP-1 medicines should inform the doctor involved if they have a planned surgery
The PRAC has recommended new measures to reduce the risk of aspiration and aspiration pneumonia in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) who undergo surgery with general anaesthesia or deep sedation.
GLP-1 RAs slow down gastric emptying as part of their action, which can lead to an increased risk of aspiration when combined with anaesthesia or deep sedation. This risk is biologically plausible and is already noted in the product information for various GLP-1 RAs, including dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide.
The committee could not definitively establish a causal link between GLP-1 analogues and aspiration. However, due to the known effect of delayed gastric emptying and the presence of cases reported in clinical trials and post-marketing, the PRAC concluded that healthcare professionals and patients should be informed about this potential risk. The product information of GLP-1 RAs will be updated accordingly.
New safety information for healthcare professionals
Glatiramer acetate: anaphylactic reactions may occur months up to years after treatment initiation
Following an EU-wide review of all available data on anaphylactic reactions associated with glatiramer acetate, a medication approved for the treatment of relapsing forms of multiple sclerosis, the PRAC has concluded that the medicine is linked to anaphylactic reactions. These reactions may occur shortly after the administration of glatiramer acetate, even after months or years of treatment. Cases with a fatal outcome have been reported.
The PRAC has approved a direct healthcare professional communication (DHPC) to inform healthcare professionals about the risk of anaphylactic reactions associated with glatiramer acetate.
