Sudafed could be BANNED or become prescription-only: Urgent probe into rare yet deadly side effect - Daily Mail
Sudafed, Nurofen and Day & Night Nurse could be BANNED or become prescription-only as officials launch probe into rare yet deadly brain side effects linked to decongestant taken by millions
- Pseudoephedrine is a decongestant found in dozens of OTC medicines
- The MHRA is now 'reviewing' evidence of serious side effects it is linked to
- The European Medicines Agency launched its own safety review two weeks ago
Sudafed could be pulled from shelves or even made prescription-only because of links to extremely rare but deadly brain disorders.
Medical regulators are 'reviewing available evidence' to see if the rules on selling pseudoephedrine need to change, it emerged today.
Health chiefs are spooked by reports of patients being struck down with two rare conditions. Both can cause strokes.
Other decongestants, such as products made by Benylin, Nurofen and Day & Night Nurse, would also be affected if any change was necessary.
Dozens of own-brand remedies — including ones at Boots and Lloyds — also contain the chemical.
It works by narrowing swollen blood vessels in the sinuses — which causes the nose to become blocked in the first place.
The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, is behind the review.
A spokesperson told MailOnline: 'We will provide any further advice as appropriate. If people have concerns, they should speak to their pharmacist or doctor.'
Whitehall sources told this website it was possible but unlikely that pseudoephedrine will be subject to a rule change following the review.
The Pharmaceutical Journal, which first reported the news, claimed it was to decide 'whether marketing authorisations for pseudoephedrine-containing medicines need to change'.
Bosses at the European Medicines Agency (EMA) launched their own review into the safety of the medicine less than a fortnight ago.
It followed 'concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)'.
EMA chiefs will 'decide whether the marketing authorisations for pseudoephedrine-containing medicines should be maintained, varied, suspended or withdrawn across the EU'.
Officials didn't specify how many cases of PRES or RCVS linked to pseudoephedrine had been spotted to warrant the probe.
EU bosses merely pointed to a 'small number' that have been logged in surveillance databases and medical literature.
The MHRA said that cases have been 'very rarely reported with these medicines'.
PRES and RCVS can involve reduced blood supply (ischaemia) to the brain and may cause major and life-threatening complications in some cases.
Signs of PRES often include headaches, vision problems, mental changes, seizures, and swelling in the brain, according to the NHS.
A severe 'thunderclap' headache is the hallmark sign of RCVS and it may be the only symptom.
Pseudoephedrine is already known to pose a slight risk to the heart including strokes and heart attacks.
And there are warnings are already included in product information leaflets inside products containing the medicine.
However, health chiefs are spooked because of new cases logged and the seriousness of PRES and RCVS.
Sales restrictions are already placed on pseudoephedrine, despite it being widely available for decades.
It has been illegal to sell or supply any product which contains more than 720mg of pseudoephedrine without a prescription since 2008.
It followed a ruling from the Commission on Human Medicines, which claimed it implemented the restriction 'to manage the risk of misuse of pseudoephedrine'.
PAGB, the Consumer Healthcare Association, told MailOnline pseudoephedrine has been available for over 40 years and has a 'well-established safety profile'.
'The safety of all medicines are continually monitored throughout their life via routine pharmacovigilance measures by both the Medicines and Health product Regulatory Agency (MHRA) and the companies that make the product.
'The MHRA has confirmed that it has begun the process to review medicines containing pseudoephedrine. This follows an announcement by the Pharmaceutical Risk Assessment Committee (PRAC), which is responsible for assessing and monitoring the safety of medicines in the EU.
'This review was instigated by France and is taking place following a small number of cases reporting two known and reversible conditions affecting blood vessels in the brain; posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
'The very rare side effects which have led to this review are already part of the known product profile and as such, warnings related to both PRES and RCVS already exist in the UK product information accompanying any UK medicine containing pseudoephedrine.'
And the association's chief executive, Michelle Riddalls, 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.
'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 any medicine containing pseudoephedrine.
'If people have any concerns about the medicines they are taking, they can speak to a pharmacist. Pharmacists are expert healthcare professionals who can provide advice and support on self-treatable conditions and consumer healthcare products.'
In the US, the US Food and Drug Administration also sets limits on how much pseudoephedrine consumers can purchase in a month-long period.
Pseudoephedrine is known to also work as an 'essential' ingredient in making crystal meth.
A spokesperson for the MHRA also told MailOnline today: '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.'
They added: 'We would also like to remind patients and parents/carers to report any suspected side effects to our Yellow Card scheme.'
All Brits are urged to report any medicines side effects they notice to the Yellow Card Scheme.
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