Sudafed can be taken off the shelves or even made by prescription because of links to extremely rare but deadly brain diseases.
As it emerged today, medical regulators are reviewing “available evidence” to determine whether the rules governing the sale of pseudoephedrine should be changed.
Health chiefs are shocked by reports of patients affected by two rare diseases. Both can cause strokes.
Other decongestants such as Benylin, Nurofen and Day & Night Nurse products will also be affected if a change is required.
Dozens of own-brand products – including those from Boots and Lloyds – also contain the chemical.
Pictured are two of the drugs sold in pharmacies that contain the chemical. Medical regulators are “reviewing available evidence” to determine whether to change the rules on the sale of pseudoephedrine, it emerged today
Health chiefs are shocked by reports of patients affected by two rare diseases. Both can cause strokes. Other decongestants such as Benylin, Nurofen and Day & Night Nurse products will also be affected if a change is required
It works by narrowing swollen blood vessels in the sinuses – which cause nasal congestion in the first place.
Behind the review is the Medicines and Healthcare products Regulatory Agency (MHRA), which oversees the safety of medicines used in the UK.
A spokesperson told MailOnline: “We will provide further advice if necessary. If people are worried, they can go to their pharmacist or doctor.”
Whitehall sources have told this website it is possible, but unlikely, that pseudoephedrine will be subject to a rule change following the review.
The Pharmaceutical Journal, which first reported the news, claimed it had to decide “whether marketing approvals for drugs containing pseudoephedrine should be changed.”
The bosses of the European Medicines Agency (EMA) launched their own investigation into the safety of the drug less than two weeks ago.
This was followed by “concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
EMA bosses will “decide whether marketing authorizations for medicines containing pseudoephedrine maintained in the EU should be changed, suspended or revoked”.
Officials did not specify how many cases of PRES or RCVS associated with pseudoephedrine were identified to warrant the investigation.
EU bosses only pointed to a “small number” recorded in surveillance databases and medical literature.
The MHRA said there have been “very rare cases reported with these drugs.”
PRES and RCVS can be associated with reduced blood flow (ischemia) to the brain and can cause serious and life-threatening complications in some cases.
Signs of PRES often include headaches, blurred vision, mental changes, seizures and swelling in the brain, according to the NHS.
A severe “thunderclap” headache is the hallmark of RCVS and may be the only symptom.
Pseudoephedrine is already known to pose a small risk to the heart, including stroke and heart attack.
And warnings are already included in product information leaflets in products containing the medicine.
But health chiefs are shocked by newly registered cases and the severity of PRES and RCVS.
Pseudoephedrine is already subject to sales restrictions, although it has been used for decades.
Since 2008, it has been illegal to sell or supply any product containing more than 720mg of pseudoephedrine without a prescription.
Dozens of own-brand drugs – including those from Boots, Lloyds and Superdrug – also contain the chemical
PRES and RCVS can be associated with reduced blood flow (ischemia) to the brain and can cause serious and life-threatening complications in some cases. Signs of PRES often include headaches, blurred vision, mental changes, seizures and swelling in the brain, according to the NHS
It followed a ruling by the Commission for Medicinal Products for Human Use, which claimed it had imposed the restriction “to manage the risk of pseudoephedrine abuse”.
In the US, the US Food and Drug Administration also sets limits on how much pseudoephedrine consumers can buy in a one-month period.
Pseudoephedrine is also known as an “essential” ingredient in the manufacture of crystal meth.
A spokesperson for the MHRA told MailOnline today: “We monitor the safety of all medicines closely to ensure that the benefits outweigh the risks – the safety of the public is our top priority.”
They added: “We would also like to remind patients and parents/carers to report suspected side effects to our yellow card scheme.”
All Britons are urged to report any drug side effects they notice to the Yellow Card scheme.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
