MHRA Drug Safety Update
The MHRA has issued a safety alert regarding very rare reports of serious neurological conditions associated with pseudoephedrine use.
What You Need to Know
Very rare cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported in patients taking pseudoephedrine. While these events are uncommon, both conditions are potentially serious and require prompt recognition and management.
Affected Medications
This alert applies to all pseudoephedrine-containing products, including:
- Over-the-counter nasal decongestants
- Combination cold and flu remedies
- Prescription formulations
Clinical Recommendations
Healthcare professionals and responders should:
- Be aware of the risk, particularly in patients presenting with headache, seizures, visual disturbances, or altered mental status after pseudoephedrine use
- Consider PRES and RCVS in the differential diagnosis when these symptoms occur
- Review patient history for pseudoephedrine exposure
- Counsel patients on appropriate use and advise them to seek immediate medical attention if symptoms develop
Further Information
For the full MHRA safety alert and additional clinical guidance, visit the MHRA Drug Safety Update page.