(2024) 27.3.2024, E.C.o. Concerning, in the Framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the Marketing Authorisations of Medicinal Products for Human Use Which Contain the Active Substance “Pseudoephedrine”.

has been cited by the following article:

• TITLE: Pseudoephedrine: A Review and Benefit-Risk Assessment with Reference to the Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)

  AUTHORS: Ronald Eccles

  KEYWORDS: Posterior Reversible Encephalopathy Syndrome (PRES), Reversible Cerebral Vasoconstriction Syndrome (RCVS), Pseudoephedrine, European Medicines Agency

  JOURNAL NAME: Open Journal of Respiratory Diseases, Vol.15 No.1, January 7, 2025

  ABSTRACT: Pseudoephedrine (PSE) is a widely used nasal decongestant. A review by the European Medicines Agency has reported that PSE may be associated with risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). PRES and RCVS are rare but serious conditions that affect cerebral blood flow. This review discusses the pharmacology of PSE and potential risks for PRES and RCVS and concludes that considering the common use of PSE, with over 70 million packs of PSE taken each year in the European Union and the United Kingdom, and the rare occurrence of PRES and RCVS, that the risks of developing PRES/RCVS on exposure to PSE are likely to be very low.