PATIENTS must be warned of very rare life-threatening side effects associated with taking popular cold and flu meds, including Sudafed and Day Nurse, officials have said.
Decongestants – which contain the ingredient pseudoephedrine – have been linked to two rare brain disorders.
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Patient information leaflets, found tucked inside medicine boxes, will be updated to “better describe” the rare risks, health chiefs said.
Doctors and pharmacists dishing out the over-the-counter (OTC) medicines must make sure patients buying these drugs are aware of the side effects.
The decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) follows four reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) in people taking the medicines.
PRES and RCVS are extremely rare but serious conditions which reduce blood supply to the brain and can cause major and life-threatening complications, including seizures and swelling of the brain.
The drugs are already known to increase the risk of heart conditions and strokes, with restrictions and warnings already included in the medicines’ product information.
Medicines with pseudoephedrine, taken orally, are used to treat nasal congestion resulting from a cold, flu or allergy and work by stimulating nerve endings to release noradrenaline, which causes the blood vessels to constrict.
Examples of pseudoephedrine-containing drugs include Sudafed, Day Nurse, Galpseud, and Boots Decongestant.
It comes as codeine linctus, a syrup used to treat dry coughs in adults, was recently changed to a prescription-only medicine due to fears people could become addicted to it.
Seek urgent medical advice
Dr Alison Cave, at the MHRA, said: “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.”
Dr Alison added that patients should “seek urgent medical advice” if they experience side effects, including “a severe headache that develops very quickly or you suddenly feel sick or are vomiting, confused or experiencing seizures or changes in vision”.
“Please report any suspected side effects to our Yellow Card scheme,” she said.
Michelle Riddalls, chief executive of PAGB, the trade association for manufacturers of over-the-counter medicines, said: “We are pleased that MHRA and its associated committees have thoroughly reviewed all the data available on pseudoephedrine and concluded that PRES and RCVS are extremely rare side effects.
“By ensuring that updates are made to the product information and widening healthcare professionals’ ability to spot these very rare reactions means that these effective decongestants remain available in pharmacies in the UK.”
What are the symptoms of PRES and RCVS?
Both PRES and RCVS are rare conditions that can lead to death if not treated.
PRES often causes headaches, vision problems, mental changes, seizures, and swelling in the brain, according to the NHS.
The symptoms of RCVS usually come on quickly and can be serious and life-threatening.
The severe “thunderclap” headache is the hallmark sign of RCVS and it may be the only symptom.
This headache often comes on abruptly, lasts for at least fine minutes and is often referred to as the ‘worst headache of your life’.
Some people report a surge of high blood pressure and seizures when the headache comes on, experts at verywellhealth explain.