New Data from EMA’s Review of Medicines with Pseudoephedrine

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has begun their review, as of Feb. 10, 2023, of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which are conditions affecting blood vessels in the brain.

PRES and RCVS can lead to reduced blood supply, or ischemia, to the brain and may lead to major and life-threatening complications in some cases. Some of the most common symptoms associated with these conditions include headache, nausea, and seizures.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy. Most pseudoephedrine-containing medicines have a known risk of cardiovascular and cerebrovascular ischemic events, such as stroke or heart attack.

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

The PRAC will continue to review available evidence and make decisions on whether the marketing authorizations for pseudoephedrine-containing medicines should be maintained, varied, suspended, or withdrawn across the EU.

Source: European Medicines Agency