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. EMA would like to thank Sabine Straus for her leadership and vision that were essential in steering the PRAC during the past six years. Her expertise and strong commitment to public health were instrumental particularly in responding to the public health challenges posed by the COVID-19 pandemic.
The Committee elected Ulla Wändel Liminga from Sweden as its new Chair. A pharmacist by training, Dr Wändel Liminga is Scientific Director of Pharmacovigilance at the Swedish Medical Products Agency – MPA - with a strong expertise in pharmacology, toxicology and pharmacovigilance. Dr Wändel Liminga has been a PRAC delegate since 2012.
More information is available in EMA’s news announcement.
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 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, the 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.
Glatiramer acetate: anaphylactic reactions may occur months up to years after treatment initiation
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. Cases with a fatal outcome have been reported. 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 of the signs and symptoms and to seek emergency care in the event of an anaphylactic reaction. If such a reaction occurs, treatment with glatiramer acetate must be discontinued.
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.
| Procedure | Status | Update |
|---|---|---|
| Metamizole containing medicinal products - referral | Under evaluation | PRAC continued its assessment |