UK – MHRA safety review of medicines containing pseudoephedrine

The MHRA is reviewing the evidence relating to the very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with medicines containing pseudoephedrine

Pseudoephedrine is used for the symptomatic relief of coughs, colds and allergies. Pseudoephedrine has been used in the UK for decades in millions and millions of people. All pseudoephedrine-containing medicines in the UK are taken orally and come in tablet, capsule, powder, liquid, or syrup form; none of the decongestant nasal sprays authorised in the UK contain pseudoephedrine.

We are reviewing the available evidence relating to the very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine-containing medicines. PRES and RCVS are rare, reversible conditions, and most patients fully recover with appropriate treatment…