European Medicines Agency assesses the safety of medicinal products containing pseudoephedrine

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) starts the assessment of the safety of medicinal products containing pseudoephedrine. The use of such products has been associated with concerns about the risk of cerebrovascular syndromes, i.e., posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Medicinal products containing pseudoephedrine are taken orally and used to treat nasal congestion.

Pseudoephedrine causes blood vessels to contract by increasing the release of noradrenaline from nerve endings. As a result, fewer fluids are released from blood vessels, reducing nasal swelling and mucus production. 

In PRES and RCVS, cerebral blood vessels contract, which may reduce the blood supply to the brain. In some cases, this may cause serious, even life-threatening complications. Common symptoms of PRES and RCVS include headache, nausea and convulsions.

The assessment is initiated based on new data on a small number of PRES and RCVS cases in patients who have used products containing pseudoephedrine as described in pharmacovigilance databases and medical literature. No adverse reactions have been recorded in Finland concerning these cases.

The use of medicinal products containing pseudoephedrine is known to increase the risk of cardiovascular events, including cerebral and myocardial infarctions. Warnings about these adverse effects and restrictions on the use of medicines are mentioned in the product information of the products. 

Combination products containing pseudoephedrine and antihistamine are sold in Finland. The trade names of these products are Acriseu, Aerinaze, Cirrus and Duact. They are all prescription medicines used for short-term treatment of allergic rhinitis. Many products containing pseudoephedrine alone or in combination with other medicinal substances are sold in the European Union. They are also used to treat flu symptoms such as headache, pain and fever. 

Based on the assessment, PRAC will issue a recommendation on marketing authorisations for medicinal products containing pseudoephedrine. The assessment will take into consideration the severity of PRES and RCVS, the therapeutic indications of products containing pseudoephedrine and their overall safety.

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EMA press release: PRAC starts safety review of pseudoephedrine-containing medicines