It has been illegal to sell or supply any product which contains more than 720mg of pseudoephedrine without a prescription since 2008. Sales restrictions are already placed on pseudoephedrine, despite it being widely available for decades. However, health chiefs are spooked because of new cases logged and the seriousness of PRES and RCVS. Pseudoephedrine is already known to pose a slight risk to the heart including strokes and heart attacks.Īnd there are warnings are already included in product information leaflets inside products containing the medicine. Signs of PRES often include headaches, vision problems, mental changes, seizures, and swelling in the brain, according to the NHS.Ī severe 'thunderclap' headache is the hallmark sign of RCVS and it may be the only symptom. PRES and RCVS can involve reduced blood supply (ischaemia) to the brain and may cause major and life-threatening complications in some cases. The MHRA said that cases have been 'very rarely reported with these medicines'. Officials didn't specify how many cases of PRES or RCVS linked to pseudoephedrine had been spotted to warrant the probe.ĮU bosses merely pointed to a 'small number' that have been logged in surveillance databases and medical literature. It followed 'concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)'.ĮMA chiefs will 'decide whether the marketing authorisations for pseudoephedrine-containing medicines should be maintained, varied, suspended or withdrawn across the EU'. The Pharmaceutical Journal, which first reported the news, claimed it was to decide 'whether marketing authorisations for pseudoephedrine-containing medicines need to change'.īosses at the European Medicines Agency (EMA) launched their own review into the safety of the medicine less than a fortnight ago. Whitehall sources told this website it was possible but unlikely that pseudoephedrine will be subject to a rule change following the review. The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, is behind the review.Ī spokesperson told MailOnline: 'We will provide any further advice as appropriate. If people have concerns, they should speak to their pharmacist or doctor.' It works by narrowing swollen blood vessels in the sinuses - which causes the nose to become blocked in the first place. Other decongestants, such as products made by Benylin, Nurofen and Day & Night Nurse, would also be affected if any change was necessary Health chiefs are spooked by reports of patients being struck down with two rare conditions.
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