BRIEF—PRAC starts safety review of pseudoephedrine-containing medicines

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee ( PRAC) 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 affecting blood vessels in the brain.

Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu or allergy.

PRES and RCVS can involve reduced blood supply (ischemia) to the brain and may cause major and life-threatening complications in some cases.

Common symptoms associated with PRES and RCVS include headache, nausea and seizures.

The review follows new data from a small number of cases of PRES and RCVS in people using pseudoephedrine-containing medicines which were reported in pharmacovigilance databases and the medical literature.

Pseudoephedrine-containing medicines have a known risk of cardiovascular and cerebrovascular ischemic events (side effects involving ischemia 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 PRES and RCVS, the overall safety profile of pseudoephedrine and the indications for which the medicines are approved, the PRAC will review available evidence and decide whether the marketing authorization for pseudoephedrine-containing medicines should be maintained, varied, suspended or withdrawn across the European Union.

Within the EU, pseudoephedrine-containing medicines are available under various trade names, including Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume, and Nurofen Cold and Flu.