Drugs of the GLP-1 (glucagon-like peptide-1) analogue class: recommendations to reduce the risk of aspiration and aspiration pneumonitis during general anesthesia or deep sedation
GLP-1 analogues are used to treat inadequately controlled type 2 diabetes, in addition to diet and regular physical activity. Some of these drugs are indicated in the management of obesity and overweight, under certain conditions.
Aspiration and aspiration pneumonitis occur when food or liquid accidentally passes into the airways instead of through the esophagus, especially if stomach contents are regurgitated into the throat. This can occur in cases where the stomach is not empty before deep sedation or general anesthesia is started. Aspiration and aspiration pneumonitis have an estimated risk of occurring in a general anesthetic procedure of between 1 in 10,000 and 1 in 900, depending on risk factors.
However, the mechanism of action of GLP-1 analogues slows down gastric emptying. This means that even if the patient is fasting for a sufficient period of time before general anesthesia or deep sedation, there is an increased risk that the stomach will not be completely empty: this is delayed gastric emptying. This delayed gastric emptying is already mentioned in the package leaflets and summaries of product characteristics (SPCs) of medicines in this pharmacological class: dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide and tirzepatide. In France, the risk of aspiration and aspiration pneumonitis is one of the potential serious adverse effects studied by the ANSM as part of its monitoring of these medicines.
The PRAC reviewed available data, including cases from spontaneous reporting, scientific literature and clinical and non-clinical data provided by the marketing authorization holders of these medicines.
The Committee was unable to establish a causal link between the use of GLP-1 analogues and the risk of aspiration during general anesthesia or deep sedation. However, the known effect of these medicines on gastric emptying and the presence of reported cases lead it to consider that healthcare professionals and patients should be informed of this potential consequence of treatment with GLP-1 analogues. Consequently, the PRAC recommended that the package leaflets and SPCs of these medicines be updated with a new warning: the possibility of residual gastric contents in patients taking GLP-1 analogues should be taken into account before any procedure under general anesthesia or deep sedation.
Patients treated with GLP-1 analogues should inform their doctor or surgeon if they are planning to undergo surgery.
In France, the drugs currently marketed are:
- Ozempic (semaglutide)
- Byetta (exenatide)
- Trulicity (dulaglutide)
- Victoza (liraglutide)
- Saxenda (liraglutide)
- Xultophy (liraglutide/insulin degludec)
Read also
- Feedback on the April 2024 PRAC (8 – 11 April)
- Standing Scientific Committee on Pharmaco-surveillance and Proper Use – Restricted training on expertise and proper use: national pharmacovigilance survey relating to GLP-1 analogues
- News – GLP-1 analogues: update on monitoring of serious adverse effects and misuse – ANSM (sante.fr)
Glatiramer acetate: Anaphylactic reactions may occur months or even years following starting treatment
Glatiramer acetate is indicated for the treatment of certain forms of multiple sclerosis (MS). Following a review of all available data on anaphylactic reactions associated with this molecule, the PRAC concluded that these reactions can occur immediately following administration, even several months or even years following the start of treatment. Fatalities have been reported. The initial symptoms of anaphylactic reactions may be confused for some with those of post-injection reactions, thus potentially delaying the recognition of an anaphylactic reaction.
A letter will soon be sent by the laboratories concerned to healthcare professionals to inform them of this risk and to recommend that patients and/or caregivers pay attention to signs and symptoms following injections, and to call for help in the event of symptoms suggestive of an anaphylactic reaction.
This is particularly important given the severity of anaphylactic reactions and the possibility of self-administration at home.
In case of an anaphylactic reaction, treatment with glatiramer acetate should be stopped.
In France, the drugs concerned are as follows:
- Copaxone 20 mg/ml, solution injectable en seringue préremplie
- Copaxone 40 mg/ml, solution injectable en seringue préremplie
- Glatiramer Viatris 20 mg/ml, solution for injection in pre-filled syringe
- Glatiramer Viatris 40 mg/ml, solution for injection in pre-filled syringe
Drugs of the GLP-1 (glucagon-like peptide-1) analogue class: recommendations to reduce the risk of aspiration and aspiration pneumonitis during general anesthesia or deep sedation
GLP-1 analogues are used to treat inadequately controlled type 2 diabetes, in addition to diet and regular physical activity. Some of these drugs are indicated in the management of obesity and overweight, under certain conditions.
Aspiration and aspiration pneumonitis occur when food or liquid accidentally passes into the airways instead of through the esophagus, especially if stomach contents are regurgitated into the throat. This can occur in cases where the stomach is not empty before deep sedation or general anesthesia is started. Aspiration and aspiration pneumonitis have an estimated risk of occurring in a general anesthetic procedure of between 1 in 10,000 and 1 in 900, depending on risk factors.
However, the mechanism of action of GLP-1 analogues slows down gastric emptying. This means that even if the patient is fasting for a sufficient period of time before general anaesthesia or deep sedation, there is an increased risk that the stomach will not be completely empty: this is delayed gastric emptying. This delayed gastric emptying is already mentioned in the package leaflets and summaries of product characteristics (SPCs) of medicines in this pharmacological class: dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide and tirzepatide. In France, the risk of inhalation and inhalation pneumonitis is one of the potential serious adverse effects studied by the ANSM as part of its monitoring of these medicines.
The PRAC reviewed available data, including cases from spontaneous reporting, scientific literature and clinical and non-clinical data provided by the marketing authorisation holders of these medicines.
The Committee was unable to establish a causal link between the use of GLP-1 analogues and the risk of aspiration during general anaesthesia or deep sedation. However, the known effect of these medicines on gastric emptying and the presence of reported cases lead it to consider that healthcare professionals and patients should be informed of this potential consequence of treatment with GLP-1 analogues. Consequently, the PRAC recommended that the package leaflets and SPCs of these medicines be updated with a new warning: the possibility of residual gastric contents in patients taking GLP-1 analogues should be taken into account before any procedure under general anesthesia or deep sedation.
Patients treated with GLP-1 analogues should inform their doctor or surgeon if they are planning to undergo surgery.
In France, the drugs currently marketed are:
- Ozempic (semaglutide) ;
- Byetta (exenatide) ;
- Trulicity (dulaglutide) ;
- Victoza (liraglutide);
- Saxenda (liraglutide) ;
- Xultophy (liraglutide/insulin degludec).
Glatiramer acetate: Anaphylactic reactions may occur months or even years following starting treatment
Glatiramer acetate is indicated for the treatment of certain forms of multiple sclerosis (MS). Following a review of all available data on anaphylactic reactions associated with this molecule, the PRAC concluded that these reactions can occur immediately following administration, even several months or even years following the start of treatment. Fatalities have been reported. The initial symptoms of anaphylactic reactions may be confused for some with those of post-injection reactions, thus potentially delaying the recognition of an anaphylactic reaction.
A letter will soon be sent by the laboratories concerned to healthcare professionals to inform them of this risk and to recommend that patients and/or caregivers pay attention to signs and symptoms following injections, and to call for help in the event of symptoms suggestive of an anaphylactic reaction.
This is particularly important given the severity of anaphylactic reactions and the possibility of self-administration at home.
In case of an anaphylactic reaction, treatment with glatiramer acetate should be stopped.
In France, the drugs concerned are as follows:
- Copaxone 20 mg/ml, solution injectable en seringue préremplie ;
- Copaxone 40 mg/ml, solution injectable en seringue préremplie ;
- Glatiramer Viatris 20 mg/ml, solution for injection in pre-filled syringe;
- Glatiramer Viatris 40 mg/ml, solution for injection in pre-filled syringe.
Read also
Feedback on the April 2024 PRAC (8 – 11 April)
Standing Scientific Committee on Pharmaco-surveillance and Proper Use – Restricted training on expertise and proper use: national pharmacovigilance survey relating to GLP-1 analogues
News – GLP-1 analogues: update on monitoring of serious adverse effects and misuse – ANSM (sante.fr)
