European regulator’s committee recommends new safety measures for medicines containing pseudoephedrine

A committee of the European Medicines Agency (EMA) has recommended new safety measures for medicines that include pseudoephedrine.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the measures to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Pseudoephedrine is a stimulant that is often used in over-the-counter decongestants in people who have a cold or allergies. It works by reducing swelling in nasal blood vessels, helping mucus and air flow more freely.

The PRAC has recommended that medicines containing pseudoephedrine should not be used in patients with high blood pressure that is severe or uncontrolled, or with severe acute or chronic kidney disease or failure.

The measures say that healthcare professionals should advise patients to stop using these medicines immediately and seek treatment if they develop symptoms of PRES or RCVS, such as severe headache with a sudden onset, feeling sick, vomiting, confusion, seizures and visual disturbances.

PRES and RCVS are rare conditions that can involve reduced blood supply to the brain, potentially causing serious, life-threatening complications.

The PRAC said its recommendations follow a review of all available evidence, including post-marketing safety data, which showed that pseudoephedrine is associated with risks of PRES and RCVS.

The product information for all pseudoephedrine-containing medicines will be updated to include the risks concerning PRES and RCVS and the new measures to be taken.

The EMA announced it had begun a review of medicines containing pseudoephedrine in February 2023. Later in the same month, the Medicines and Healthcare products Regulatory Agency (MHRA) told The Pharmaceutical Journal that it was reviewing available evidence on the risk of PRES AND RCVS for medicines containing pseudoephedrine.

On 4 December 2023, a spokesperson for the MHRA told The Pharmaceutical Journal that they could not comment on the timescale for its own review, but added: “Medicines containing pseudoephedrine are already contraindicated in patients with cardiovascular disease, including hypertension, as well as those with severe renal impairment. 

“As we have communicated before, if signs or symptoms of PRES/RCVS develop, pseudoephedrine should be discontinued and medical advice sought immediately.

“We would recommend that patients speak with their pharmacist should they have any concerns regarding their pre-existing conditions and the use of these medicines.”