MHRA Publishes a safety review on medicines containing Pseudoephedrine

March 14, 2024

Pseudoephedrine is licensed for the symptomatic relief of nasal and sinus congestion in colds, flu, and allergies. It has been used in the UK for decades by millions of people. All pseudoephedrine-containing medicines in the UK are for short term use and taken orally. These come in tablet, capsule, powder, liquid, or syrup form; none of the decongestant nasal sprays authorised in the UK contain pseudoephedrine.

There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine. These are very rare conditions that can involve inflammation and/or reduced blood supply to the brain, which are recognised as very rare side effects for pseudoephedrine-containing medicines licensed in the UK, Following a careful MHRA review of the latest available evidence, including the assessment of cumulative reporting of adverse drug reaction reports, the safety information of all pseudoephedrine-containing medicines will be updated to provide clearer descriptions of these risks and potential risk factors for these conditions for both patients and healthcare professionals, This decision follows independent advice from the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM). The PEAG recommended updates to the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) and advised that the MHRA remind healthcare professionals and patients of these risks.

No one should take pseudoephedrine if they have very high blood pressure (hypertension) or hypertension not controlled by their medicines, or if they have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure. It is important that patients speak to their doctor or pharmacist if they are unsure. Patients who develop symptoms of PRES and RCVS should stop taking pseudoephedrine immediately and seek urgent medical attention. Symptoms include severe headache that develops very quickly or suddenly feeling sick or vomiting, confusion or experiencing seizures or changes in vison.

Advices to Healthcare professionals and Patients at: Pseudoephedrine: very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) - GOV.UK (www.gov.uk)

Learn more at: Update on MHRA safety review of medicines containing pseudoephedrine - GOV.UK (www.gov.uk)

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