Brussels, 17 January 2025 – New, comprehensive review, “Pseudoephedrine: A Review and Benefit-Risk Assessment with Reference to the Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS),” authored by Professor Ronald Eccles, offers an in-depth evaluation of the pharmacology of pseudoephedrine (PSE) and assesses its associated benefits and risks. With over 70 million packs consumed annually in the European Union (EU) and the United Kingdom (UK), the review concludes that the likelihood of developing PRES or RCVS in the context of PSE use is exceptionally low, considering its widespread usage.

Pseudoephedrine is a key ingredient in many non-prescription products used by millions to manage nasal and sinus congestion. These include formulations combined with analgesics, antihistamines, and cough medicines.

The analysis by Professor Eccles builds upon a recent review by the European Medicines Agency (EMA) of potential risks of PRES and RCVS associated with PSE-containing medicines. Following the review, regulatory measures were implemented to minimize these risks, including updated warnings and contraindications for certain high-risk patients.

While PRES and RCVS are rare but serious conditions affecting cerebral blood flow, Professor Eccles states: “PSE has sympathomimetic properties and, therefore, has the potential to cause vasoconstriction and tachycardia. However, the low OTC doses of PSE have little effect on the cardiovascular system. […] Any causal relationship between the use of PSE and adverse events of PRES/RCVS is unlikely […].”

AESGP’s Perspective

AESGP Director General, Jurate Svarcaite, emphasized the importance of this review, saying: “This new expert review highlights the importance of evidence-based assessment in guiding regulatory actions. Pseudoephedrine remains a trusted self-care solution for millions of individuals across Europe, and this publication reaffirms its safety and efficacy when used as directed.”

Document

The full article is available in the Open Journal of Respiratory Diseases, February 2025 issue.

• Eccles, R. (2025) Pseudoephedrine: A Review and Benefit-Risk Assessment with Reference to the Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS). Open Journal of Respiratory Diseases, 15, 19-34. doi: 4236/ojrd.2025.151002.