Pseudoephedrine – Update on Risks in Hypertension, CKD and Renal Failure

Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

The Propriety Association of Great Britain (PAGB), in association with the MHRA, has today written to health professionals about risks identified following a review of pseudoephedrine-containing products. This follows the publication of Volume 17 of the MHRA Drug Safety Update of the 7th of February, 2024. The communication from the PAGB has the following points:

1. Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicines.
2. Pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease or renal failure, as these conditions increase the risks of PRES or RCVS.
3. Symptoms of PRES and RCVS include sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.
4. Patients should be advised to immediately stop using these medicines and seek medical assistance if signs or symptoms of PRES or RCVS develop.

Source: Gov.uk

Additional Information

The communication includes some additional background information on PRES and RCVS, as well as a call to report suspected cases. Specifically, it shares the following information:

1. PRES can manifest with a wide variety of acute or subacute neurological symptoms, including headache, mental status alteration, seizures, visual disturbances and/or focal neurologic deficits. An acute or sub-acute onset of the symptoms (hours to days) is typical. PRES is usually reversible; symptoms cease within several days or weeks with the reduction of blood pressure and withdrawal of causative drugs.
2. RCVS usually manifests with thunderclap headache (severe pain peaking in seconds), typically bilateral, with posterior onset followed by diffuse pain frequently accompanied by nausea, vomiting, photophobia and phonophobia. Transient focal deficits can be present in some patients. Ischaemic and haemorrhagic stroke are the major complications of the syndrome.

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This is important for pharmacy professionals in general practice as we encounter a lot of patients with viral upper respiratory illnesses, for whom antibiotics and not indicated and self-care via over-the-counter products may be an option.

You may find more MHRA updates of relevance to pharmacy professionals in general practice here.