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