The Medicines and Healthcare
products Regulatory Agency 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.
Since these products were authorised, we have received two UK
Yellow Card reports of these possible side effects associated
with pseudoephedrine, despite very widespread usage. The
potential risk is considered to be very rare.
If signs or symptoms of PRES/RCVS develop, pseudoephedrine should
be discontinued, and medical advice sought immediately. Symptoms
reported include sudden onset of severe headache, nausea,
vomiting, seizures, confusion and visual disturbances.
We would also like to remind patients and parents/carers to
report any suspected side effects to our Yellow Card scheme.
We will provide any further advice as appropriate.
If you have any concerns about your medicine, please seek advice
from a healthcare professional.
Further information:
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Posterior reversible encephalopathy syndrome (PRES), also
known as reversible posterior leukoencephalopathy syndrome
(RPLS), is a rare condition in which parts of the brain are
affected by swelling, usually as a result of an underlying
cause. Someone with PRES may experience headache, changes in
vision, and seizures, with some developing other neurological
symptoms such as confusion or weakness of one or more limbs.
Most patients fully recover from this condition.
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Reversible cerebral vasoconstriction syndrome (RCVS) is a
neurological disorder characterised by a sudden onset of
severe headache associated with narrowing of blood pipes
(intracranial vessels) that supply blood to the brain. On
brain imaging the narrowing of the blood vessels can look
similar to “string of beads”. In addition to headaches RCVS
can also present as medical emergency with strokes (ischaemic
strokes or bleed), seizure or as brain oedema (brain
swelling). Usually, the narrowing resolves by itself within
three months hence it is called reversible vasoconstriction.
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PRES and RCVS have previously been identified as very rare
potential side effects associated with pseudoephedrine
containing products.
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The European Medicines Agency’s safety committee (PRAC) is
also conducting a review
of pseudoephedrine.
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The Medicines and Healthcare products Regulatory Agency
(MHRA) is responsible for regulating all medicines and
medical devices in the UK by ensuring they work and are
acceptably safe. All our work is underpinned by robust and
fact-based judgements to ensure that the benefits justify any
risks. The MHRA is an executive agency of the Department of
Health and Social Care.
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The MHRA reviews reports of suspected side effects via
the Yellow Card
Scheme, run by the MHRA and the Commission on Human
Medicines. The scheme collects and monitors information on
suspected safety concerns involving healthcare products
through voluntary reporting by the public (including
patients, parents and carer givers) as well as from
healthcare professionals.
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The nature of Yellow Card reporting means that reported
events are not always proven side effects. Some events may
have happened anyway.
