Britain’s MHRA (Medicines and Healthcare products Regulatory Agency) has reviewed the latest evidence relating to the very rare risk of side effects associated with medicines containing pseudoephedrine, and updated its safety information for both doctors and patients.
Pseudoephedrine, which has been used for decades by millions of people, is licensed for the symptomatic relief of nasal and sinus congestion in colds, flu and allergies.
There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine. Both conditions 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.
After 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.
Patients who develop symptoms of PRES and RCVS should be told to 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.
Dr Alison Cave, MHRA chief safety officer, said that the neurological conditions of PRES and RCVS had been previously identified as very rare potential side effects associated with pseudoephedrine-containing products.
“After a thorough review of new safety data, product information for all pseudoephedrine-containing medicines will be updated to better describe these very rare risks and the potential risk factors associated with these conditions.
“We remind healthcare professionals … that pseudoephedrine is for short term use only and should only be used to relieve symptoms of nasal and sinus congestion in colds, flu, and allergies.”
To date, the MHRA has received four Yellow Card reports of suspected PRES or RCVS associated with pseudoephedrine. This is in the context of widespread usage with more than 4m packets sold in the UK in 2022 alone.
Gov.UK article – Update on MHRA safety review of medicines containing pseudoephedrine (Open access)
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