PRAC February 2023 – Start of a safety review of pseudoephedrine-containing medicines
March 2, 2023
During its February 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started a review of medicines containing pseudoephedrine.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions involving problems with blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion (a blocked nose) resulting from a cold, flu or allergy.
PRES and RCVS can involve reduced blood supply (ischaemia) to the brain and may cause major and life-threatening complications in some cases. Common symptoms associated with PRES and RCVS include headache, seizures, nausea and an altered mental status.
The review follows new data from a small number of cases of PRES and RCVS in people using pseudoephedrine-containing medicines and which were reported in pharmacovigilance databases and the medical literature.
Pseudoephedrine-containing medicines have a known risk of cardiovascular and cerebrovascular ischaemic events (side effects involving ischaemia in the heart and brain), including stroke and heart attack. Restrictions and warnings are already included in the medicines’ product information to reduce these risks.
Considering the seriousness of RCVS and PRES, the overall safety profile of pseudoephedrine and the benign indications for which the medicines are approved, the PRAC will review available evidence and decide whether the marketing authorisations for pseudoephedrine-containing medicines should be maintained, varied, suspended or withdrawn across the EU.
Pseudoephedrine-containing medicines are authorised in various EU Member States alone or in combination with medicines to treat symptoms of a cold and flu such as headache, fever and pain, or allergic rhinitis (inflammation of the nasal passages) in people with nasal congestion.
The following pseudoephedrine-containing medicines are authorised and on the market in Belgium:
• Vasocedine Pseudoephedrine;
• Sinutab Forte;
More information is available on the EMA website.