Sudafed, Nurofen cold & flu and Day Nurse may be banned over brain disorder link
Sudafed, Nurofen cold & flu and Day Nurse could all be banned or become prescription only as medical regulators investigate links to two extremely rare but deadly brain disorders.
Officials are said to be reviewing evidence to see if the rules on selling the drug pseudoephedrine need to change.
Any changes would effect decongestants like Benylin, Nurofen cold & flu and Day Nurse - some of the most common cold medicines used by Brits.
The sudden review has come about after health chiefs were left allegedly spooked after reports of patients suffering from two rare conditions as a result of the drug.
The Medicines and Healthcare products Regulatory Agency are "reviewing available evidence" they told The Mirror and the investigation would decide whether the rules around the pseudoephedrine-medicines needed to change.
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But Whitehall sources told the Mail Online that any change was unlikely.
The drug works by narrowing swollen blood vessels in the sinuses, which is what causes blocked noses but there are fears it could be linked to two disorders which can affect the brain.
Meanwhile, health chiefs at the European Medicines Agency (EMA) started their own review into the drug just a few weeks ago.
This comes "following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain."
A "small number of cases of PRES and RCVS", officials didn't confirm how many, linked to people taking pseudoephedrine-containing medicine triggered the review.
The two conditions lead to a reduced blood supply to the brain which can cause life-threatening complications and death.
Sudafed helps clear sinuses (Internet unknown)According to the NHS, PRES has a number of symptoms including headaches, vision problems, mental changes, seizures and even swelling on the brain.
The most telling symptom of RCVS is a severe "thunderclap" headache.
Pseudoephedrine-containing medicines are already known to have a very small risk of cardiovascular or cerebrovascular diseases - this includes heart attacks and strokes.
Warnings about such issues are included in product information leaflets and there are sale restrictions in place on such drugs to stop too large an amount being sold at once.
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However the drugs are sold and used daily almost without incident.
But what reportedly scared health chiefs into acting was the severity of the latest cases.
An MHRA spokesperson said: “We keep the safety of all medicines under close review to ensure that the benefits outweigh any risks - the safety of the public is our top priority.
“We are reviewing the available evidence regarding the use of medicines containing pseudoephedrine and the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which have been very rarely reported with these medicines. We will provide any further advice as appropriate.
“We would also like to remind patients and parents/carers to report any suspected side effects to our Yellow Card scheme.”
“If you have any concerns about your medicine, please seek advice from a healthcare professional.”
The MHRA received two reports of the disorders, through their Yellow Card scheme, linked to pseudoephedrine-containing medicines.
One saw a patient suffer from PRES but recover but a second saw someone suffer from RCVS, but it isn't known if they survived.
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