Multiple over-the-counter medicines face being BANNED after link to rare brain disorder

Over-the-counter medicines including Sudafed and Night Nurse are to be reviewed over concerns linking them to rare brain disorders.

The health watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), is to review evidence available on potential side effects of medicines containing pseudoephedrine.

A number of over-the-counter medicines include the drug, such as Sudafed, Night and Day Nurse, Nurofen Cold and Flu as well as some Benylin products.

Andy Buchanan

The European Medicines Agency (EMA) has previously launched a review after concerns were raised over two conditions which affect blood vessels in the brain, causing major complications.

The pharmacovigilance risk assessment committee will examine the evidence before deciding if such medicines should be suspended, withdraw or made prescription only.

Medicines containing pseudoephedrine are use to tackle nasal issues caused by colds, flus or allergies, stimulating nerve endings to release noradrenaline. This causes blood vessels to constrict.

Product information within the medicines warn of other major problems, which include the increase the risk of strokes and heart conditions.

Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) are the two conditions under review.

The conditions, whilst both extremely rare, are considered serious.

Customers are not being told to stop using the product whilst under review, and they will still be available from pharmacies.

In a statement given to The Pharmaceutical Journal, the MHRA 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.”

The MHRA said they had received two reports of cases that were linked to pseudoephedrine products. In one case of PRES the patient recovered, and one RCVS case where the outcome is unknown.