Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023

1 December 2023

PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine.

EMA’s safety committee, PRAC, has recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Pseudoephedrine is a stimulant that is often used as a decongestant in people who have a cold or allergies. 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 are described further in the section below “New safety information for healthcare professionals”.

The PRAC’s 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.

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.

More information is available in EMA’s public health communication.

New safety information for healthcare professionals: minimising risks with pseudoephedrine-containing products

As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed a direct healthcare professional communication (DHPC) with important information on pseudoephedrine-containing products.

The DHPC will inform healthcare professionals about the risk minimisation measures for side effects of PRES and RCVS associated with these medicines.

The DHPC for medicines containing pseudoephedrine will be forwarded to EMA’s human medicines committee (CHMP). When adopted, the DHPCs 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.

GLP-1 receptor agonists’ review: PRAC requests further clarifications from marketing authorisation holders

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 agonists¹. While at this point no conclusion can be drawn on a causal 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 PRAC will rediscuss this topic at its meeting in April 2024. EMA will communicate further when new information is available.

---

¹ Dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide

 

Agenda

Agenda of the PRAC meeting 27-30 November 2023

Draft Reference Number: EMA/PRAC/477373/2023

PRAC statistics: December 2023

PRAC statistics: December 2023

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
Hydroxyprogesterone-containing medicinal products – Article-31 referral	Under evaluation	PRAC continued its assessment