EMA to Review Pseudoephedrine Drugs

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will review data on medicines containing pseudoephedrine hydrochloride following reports that the decongestant drugs are associated with two potentially serious vasoconstrictive brain conditions.

The review was sparked by a number of reported cases of two conditions affecting blood vessels in the brain — posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) — occurring in people using pseudoephedrine-containing medicines.

The committee will review the evidence and decide whether the marketing authorizations for pseudoephedrine-containing medicines should be “maintained, varied, suspended or withdrawn across the EU,” the agency said.