Safety review into nasal decongestants due to rare brain risk

Assessments are underway into a very rare but potentially serious brain side effect of nasal decongestants bought on the High Street.

Those containing pseudoephedrine are being reviewed as they may cause vessels supplying the brain to spasm or contract, reducing blood flow, leading to seizures and strokes.

However, drug regulators stress the likelihood of this happening is extremely low.

Experts will look at two brain blood vessel conditions – reversible cerebral vasoconstriction syndrome (RCVS) and posterior reversible encephalopathy syndrome (PRES).

The review was initiated after regulators in France alerted European drugs regulator the EMA about some recent rare cases.

In the UK, suspected side effects can be reported to the Yellow Card scheme, which is run by the Medicines and Healthcare Products Regulatory Agency (MHRA).

The Royal Pharmaceutical Society (RPS) said pseudoephedrine was widely used and that medicines like this were carefully assessed before being made available to the public.

Professor Claire Anderson, president of the RPS, said “When new risks come to light it can be worrying for patients.  It’s right that they are investigated by the appropriate authorities and we await the outcome of the EMA and MHRA reviews.”

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Posted by Karen Motley, Clinical Negligence Department, Chadwick Lawrence LLP (tonymay@chadlaw.co.uk ), medical negligence lawyers and clinical negligence solicitors in Huddersfield, Leeds, Wakefield and Halifax, West Yorkshire.

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