Following an EU-wide review, and a review by the Medicines and Healthcare products Regulatory Agency (MHRA) of UK reports, with advice from the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM), it has been concluded that pseudoephedrine is associated with risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
A DHPC letter has been sent to healthcare providers from PAGB on behalf of the Marketing Authorisation Holders of medicines containing pseudoephedrine, including a summary of MHRA’s notice and background on the safety concern, with an overview of PRES and RCVS.
For further details, read the letter.
