During its December 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended new measures for medicines containing pseudoephedrine to minimise the risk of serious side effects and requested further clarifications in the framework of the GLP-1 receptor agonists’ review.
Pseudoephedrine-containing medicines
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
PRES and RCVS are rare conditions that can involve reduced blood supply to the brain, potentially causing serious, life-threatening complications. With prompt diagnosis and treatment, symptoms of PRES and RCVS usually resolve.
Medicines containing pseudoephedrine are not to be used in patients with high blood pressure that is severe or uncontrolled (not being treated or resistant to treatment), or with severe acute (sudden) or chronic (long-term) kidney disease or failure.
Healthcare professionals should advise patients to stop using these medicines immediately and seek treatment if they develop symptoms of PRES or RCVS, such as severe headache with a sudden onset, feeling sick, vomiting, confusion, seizures and visual disturbances.
The recommendations follow a review of all available evidence, including post-marketing safety data, which showed that pseudoephedrine is associated with risks of PRES and RCVS. During the review, PRAC sought advice from an expert group of general practitioners, otorhinolaryngologists (specialists in diseases of the ear, nose, throat, head and neck), allergologists (specialists in the treatment of allergies) and a patient representative. PRAC also considered information submitted by a third party representing healthcare professionals.
The product information for all pseudoephedrine-containing medicines will be updated to include the risks concerning PRES and RCVS and the new measures to be taken. Restrictions and warnings are already included in the product information of these medicines to reduce cardiovascular and cerebrovascular ischaemic (involving reduced blood supply to the heart and brain) risks.
The PRAC recommendations will now be sent to EMA’s human medicines committee (CHMP), which will adopt the Agency’s final opinion.
In Belgium, medicines containing pseudoephedrine are authorised and marketed under the following names:
- Aerinaze;
- Vasocedine Pseudoephedrine;
- Cirrus;
- Rhinosinutab;
- Clarinase Repetabs;
- Clarinase Once Daily;
- Sinuphene;
- Parasineg;
- Sinutab;
- Sinutab Forte;
- Therafixx-CapitaNasal.
More information is available on the EMA website.
GLP-1 receptor agonists review
The PRAC has reviewed the available evidence from clinical trials, post-marketing surveillance and the published literature on reported cases of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists (Dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide). While at this point no conclusion can be drawn on a casual association, there are several issues that still need to be clarified. The committee has agreed further lists of questions to be addressed by the respective marketing authorisation holders for these medicines, namely Ozempic, Rybelsus, Wegovy, Victoza, Saxenda, Xultophy, Byetta, Bydureon, Lyxumia, Suliqua and Trulicity.
The review is expected to conclude in April 2024. EMA will communicate further when new information is available.
In Belgium, analogues of the incretin hormone glucagon-like peptide-1 (GLP-1), an intestinal hormone which ensures glycaemic control, are authorised and marketed under the following names:
- medicines with the active substance liraglutide: Victoza;
- medicines with the active substance exenatide: Bydureon;
- medicines with the active substance dulaglutide: Trulicity;
- medicines with the active substance semaglutide: Ozempic et Rybelsus.
More information is available on the EMA website.