Experts from the Medicines and Healthcare Products Regulatory Agency (MHRA) have conducted a review of nasal decongestants on the Brain, that contain pseudoephedrine, a drug that can help clear blocked airways and reduce stuffiness.
The review was initiated after regulators in France alerted the European drugs regulator, the EMA, about rare cases of brain side effects caused by the drug.
The concern is that pseudoephedrine may cause vessels supplying the brain to contract or spasm, reducing blood flow. This could potentially lead to seizures and even a stroke.
Two brain blood vessel conditions, posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), are being assessed by experts.
Symptoms of PRES may include blurred vision, headache, seizures, and confusion, while RCVS can cause sudden, severe thunderclap headaches that often recur over a span of days to weeks.
The MHRA in the UK has received a very small number of recent reports of brain side effects caused by pseudoephedrine, including one case of PRES where the person recovered, and one for RCVS where the outcome was reported as unknown.
Side Effects on the Brain
The MHRA has emphasized that the likelihood of brain side effects is extremely low and that products already include warnings about the rare risks on patient information leaflets that come with the medicines, as well as more common side effects such as headache and dizziness.
The Royal Pharmaceutical Society (RPS) has said that pseudoephedrine is widely used and that medicines like this are carefully assessed before being made available to the public.
RPS president Prof Claire Anderson 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.”
People who are concerned about medication should speak to a doctor or pharmacist. All medicines can have some side effects, and it is important to weigh the benefits against the risks before taking any medication.
In the UK, people can report any suspected side effects from medicines to the Yellow Card scheme, which is run by the MHRA. The MHRA keeps the safety of all medicines under close review to ensure that the benefits outweigh any risks, and the safety of the public is its top priority.
The agency is reviewing the available evidence and will provide any further advice as appropriate.
The review was initiated after regulators in France alerted the European drugs regulator, the EMA, about rare cases of brain side effects caused by the drug.
The MHRA in the UK has received a very small number of recent reports of brain side effects caused by pseudoephedrine, but the agency has emphasized that the likelihood of brain side effects is extremely low.
It is important for people who are concerned about medication to speak to a doctor or pharmacist and to report any suspected side effects from medicines to the Yellow Card scheme.
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