PAGB statement on the review of pseudoephedrine

Available for over 40 years and with a well-established safety profile, pseudoephedrine is an active ingredient which is used as a decongestant in a variety of cold and flu products that are sold under the supervision of a pharmacist.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 extremely 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 medicines containing pseudoephedrine.PAGB – The Consumer Healthcare 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 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.“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.”ENDS Notes to editors:      PAGB, the consumer healthcare association, represents the manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK.  For further information please contact Farhana Hawthorn, Media and Public Affairs Manager,, 07522616526   

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