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MHRA to review safety of pseudoephedrine products

Pharmacy News

MHRA to review safety of pseudoephedrine products

The MHRA is reviewing the safety of medicines containing pseudoephedrine.

The move 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 Proprietary Association of Great Britain (PAGB), the trade body representing OTC manufacturers, said that these extremely rare side-effects are already part of the known product profile and added that warnings related to both PRES and RCVS already exist in the UK product information accompanying medicines containing pseudoephedrine.  

Chief executive, Michelle Riddalls, said: “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 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 [under the supervision of a pharmacist].”

Sales restrictions have been in place since 2008 to manage the risk of misuse of pseudoephedrine and ephedrine following advice from the Commission on Human Medicines.




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