Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024
PRAC elects new chair
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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. 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.
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 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.
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 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.
Agenda
PRAC statistics: July 2024
Glossary:
- Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under 'Signal management'.
- Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under 'Periodic safety update reports: questions and answers'.
- Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans'.
- Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under 'Post-authorisation safety studies'.
- Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures.
- Summary safety reports have been introduced as part of the enhanced safety monitoring of COVID-19 vaccines. Marketing authorisation holders are required to submit these reports to EMA, starting on a monthly basis. Their submission complements the submission of PSURs. For more information see Pharmacovigilance plan of the EU Regulatory Network for COVID-19 vaccines.
Ongoing referrals
| Procedure | Status | Update |
|---|---|---|
| Metamizole containing medicinal products - referral | Under evaluation | PRAC continued its assessment |