PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
EMA’s safety committee, PRAC, has recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Pseudoephedrine is a stimulant that is often used as a decongestant in people who have a cold or allergies. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain, potentially causing serious, life-threatening complications. With prompt diagnosis and treatment, symptoms of PRES and RCVS usually resolve.
Medicines containing pseudoephedrine are not to be used in patients with high blood pressure that is severe or uncontrolled (not being treated or resistant to treatment), or with severe acute (sudden) or chronic (long-term) kidney disease or failure…
