During its July 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued new recommendations for GLP-1 receptor agonists and agreed a direct healthcare professional communication for glatiramer acetate containing products.
GLP-1 receptor agonists
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued 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 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. GLP-1 RAs are medicines used for treatment of type 2 diabetes and obesity.
Aspiration and pneumonia aspiration can be caused by accidentally inhaling food or liquid into an airway instead of swallowing it through the oesophagus (the tube that connects the throat to the stomach). It can also occur when stomach content goes back into the throat. Aspiration and pneumonia aspiration complicate between one in 900 to one in 10 000 general anaesthesia procedures, depending on risk factors.
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 Summaries of Product Characteristics (SPC) and the leaflets 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 PRAC 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, the PRAC considered that healthcare professionals (HCPs) and patients should be informed on this potential consequence of delayed gastric emptying.
Therefore, the PRAC 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 SPC and leaflets 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.
The following medicines containing a GLP-1 receptor agonist, an intestinal hormone that ensures glycemic control, are autorised in the European Union (EU) and on the market in Belgium:
- medicines containing the active substance dulaglutide: Trulicity;
- medicines with the active substance exanetide: Bydureon;
- medicines with the active substance liraglutide: Victoza;
- medicinal products with the active substance semaglutide: Ozempic and Rybelsus.
More information is available on the EMA website.
Glatiramer acetate containing medicines
Anaphylactic reactions may occur months up to years after treatment initiation with glatiramer acetate.
Following an EU-wide review of all available data concerning anaphylactic reactions with glatiramer acetate, a medicine authorised for the treatment of relapsing forms of multiple sclerosis, the PRAC concluded that the medicine is associated with anaphylactic reactions which may occur shortly following administration of glatiramer acetate even after months up to years after initiation of treatment. Initial symptoms of anaphylactic reactions may overlap with symptoms of post-injection reaction and could potentially lead to a delay in the identification of an anaphylactic reaction.
The PRAC has agreed a direct healthcare professional communication (DHPC) to inform healthcare professionals about this risk and to recommend that patients and/or caregivers be advised to seek emergency care in the event of an anaphylactic reaction. If such a reaction occurs, treatment with glatiramer acetate must be discontinued.
The DHPC approved by the PRAC was forwarded to the Committee for Medicinal Products for Human use (CHMP) of the EMA for approval.
Once adopted, the DHPC for glatiramer acetate will be disseminated to healthcare professionals by the marketing authorisation holders, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.
The following medicines containing glatiramer acetate are autorised and on the market in Belgium:
• Copaxone;
• Glatiramyl.
More information is available on the EMA website.