Regulator reviewing cold and flu decongestants containing pseudoephedrine over rare brain risk

A health watchdog is looking into safety concerns about a decongestant in several over-the-counter medicines. Martin Stew has the latest

The medicines regulator has launched a review of cold and flu remedies containing pseudophedrine, due to rare but potentially serious brain side-effect risks.

The Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing the risks of oral drugs containing the active ingredient, emphasising the risk to the brain is 'very rare.'

Medicines containing pseudoephedrine are sold by High Street pharmacists, and routinely taken as oral decongestants to treat a blocked or stuffy nose.

The UK-wide review concerns links between products containing the active ingredient, and posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

The agency did not name any particular brands of products in its statement announcing the review on Thursday.

PRES and RCVS have previously been identified as potential side effects with these products, the MHRA said.

The regulator advises that if signs or symptoms of PRES/RCVS develop, pseudoephedrine should be discontinued, and medical advice sought immediately.

The MHRA's action was prompted following the launch of an EU-wide review, and after the regulator received a 'very small' number of unique UK Yellow Card reports of these events with pseudoephedrine products.

In one case the patient recovered from PRES, and in another case the patient's outcome after being struck by RCVS was unknown.

The MHRA sought to clarify that decongestant nasal sprays don’t contain pseudoephedrine and are not affected by the review.

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 PAGB, a consumer healthcare association which represents the manufacturers of branded over-the-counter medicines, self-care medical devices and food supplements in the UK, issued a statement on the review.  

Chief Executive Michelle Riddalls, said products containing pseudoephedrine remained an effective treatment, and anyone concerned should ask their pharmacist for advice.

“A routine safety review has been instigated at an EU level. This is in relation to a potential, but extremely rare, known side effect. Only two reports of PRES and RCVS have been reported in the UK and both cases were treated successfully. 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.

“In the meantime, OTC products containing pseudoephedrine remain an effective treatment option for those needing to use products containing a decongestant. Relevant warnings related to both PRES and RCVS already exist in the UK product information accompanying medicines containing pseudoephedrine."

Want a quick and expert briefing on the biggest news stories? Listen to our latest podcasts to find out What You Need To know...