United Kingdom: Pseudoephedrine is licensed for the relief of nasal and sinus congestion in colds, flu, and allergies and has been used by millions of people in the UK for decades. All medicines containing pseudoephedrine in the UK are intended for short-term oral use.
They come in a variety of forms such as tablets, capsules, powders, liquids, or syrups. None of the nasal sprays approved in the UK contain Pseudoephedrine. As a result of Pseudoephedrine, Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) have been reported in rare cases. These are infrequent side effects of Pseudoephedrine-containing medicines licensed in the United Kingdom, involving inflammation or reduced blood supply to the brain.
Following a careful study by the Medicines and Healthcare Products Regulatory Agency (MHRA) of the latest available proof, including an assessment of cumulative reporting of adverse drug reaction reports, the Safety Information for all pseudoephedrine-containing medicines will be updated to provide clearer reports of these perils. Potential threat factors for these conditions for patients and healthcare professionals.
The finding was developed in accordance with independent guidance from the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM). PEAG suggested that the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) be updated and the MHRA be reminded of these risks.
In addition, Pseudoephedrine should not be taken by anyone with extremely high blood pressure (hypertension) or hypertension that cannot be controlled by medication, or with severe acute (sudden) or chronic (long-term) kidney disease or kidney failure. If patients are uncertain, they should consult their doctor or pharmacist.
It is recommended that patients stop taking Pseudoephedrine immediately if they develop symptoms of PRES or RCVS, and seek medical attention as soon as possible. The most common symptoms include a sudden and severe headache, feeling sick or vomiting, confusion, or experiencing seizures.
MHRA chief safety officer, Dr. Alison Cave, said that, “The neurological conditions of PRES and RCVS have been previously identified as very rare potential side effects associated with Pseudoephedrine-containing products. Following 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 and patients 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. If you experience a severe headache that develops very quickly or you suddenly feel sick or are vomiting, confused or experiencing seizures or changes in vision while taking this medicine, stop taking it immediately and seek urgent medical attention. Please report any suspected side effects to our Yellow Card scheme,” Cave remarked.
A total of four Yellow Card reports have been received by the MHRA concerning suspected PRES or RCVS associated with Pseudoephedrine. With over 4 million packets being sold in the UK alone in 2022, this is in the context of widespread use.
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