Health watchdogs are to review the safety of over-the-counter medicines, including Sudafed and Day Nurse, amid concern about links to rare brain disorders.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is reviewing the available evidence on potentially serious side effects linked to medicines containing pseudoephedrine.
It came after the European Medicines Agency (EMA) launched a review, following concerns over the risk of two conditions which affect blood vessels in the brain and can cause major and life-threatening complications.
Medicines with pseudoephedrine, which are 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.
The drug is contained in a host of over-the-counter medicines, including Sudafed, Day Nurse, Nurofen Cold and Flu and some Benylin products.
The medicines are known to increase the risk of heart conditions and strokes, with restrictions and warnings already included in the medicines’ product information.
The new review is examining the risks of two conditions: posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Both are extremely rare.
Customers will not be told to stop using the products while the review is ongoing and pharmacists have not been advised to remove any of the items.
Earlier this month, the EMA began a review which will examine the overall safety profile of pseudoephedrine and indications for which the medicines are approved.
Its pharmacovigilance risk assessment committee will review the evidence to decide whether such medicines should be suspended, withdrawn, maintained or made prescription only.
Available data to be assessed
The Pharmaceutical Journal has now reported that the MHRA is also “reviewing the available evidence”.
An MHRA spokesman 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.”
Two reported cases linked to drug
The MHRA said it had received two such reports linked to pseudoephedrine products: one of PRES where the patient recovered, and one for RCVS where the outcome was reported as unknown.
A spokesman for the Royal Pharmaceutical Society told the Pharmaceutical Journal that pharmacists were “well aware” of the risks of misuse of pseudoephedrine and “manage those effectively”.
“When new risks come to light it’s right that they are investigated by the appropriate authorities and we await the outcome of the EMA and MHRA reviews,” he said.
Michelle Riddalls, chief executive of PAGB, the trade association for manufacturers of over-the-counter medicines, said: “A routine safety review has been instigated at an EU level. This is in relation to a potential, but very rare, known side effect. Warnings related to these concerns are already present on the product information in the UK. However as is right, MHRA will also being making an assessment to see if any changes are needed in the UK.
“There are no immediate changes to medicines containing pseudoephedrine and any suggestions speculating the outcome of the MHRA review would be inappropriate and premature.
“Safety is of paramount importance to the over-the-counter (OTC) medicines industry. Those manufacturers with products containing pseudoephedrine will be providing data to both MHRA and EU regulators to allow a full benefit and risk analysis to take place. We will be fully supporting this risk analysis process in providing the necessary data.”
