The medicines regulator has changed guidance on decongestant nasal sprays, capping recommended use of some products at five days.
It follows two reports by ITV News revealing the scale of so-called nasal spray “addiction”, with millions of people in the UK potentially having used the product long enough to put themselves at risk.
The MHRA also announced leaflets will contain “strengthened” wording on the risks of prolonged use.
Nasal sprays and drops containing xylometazoline and oxymetazoline can relieve congestion, but they are only meant to be used on a short-term basis.
Overusing them may lead to a condition known as rebound congestion, or rhinitis medicamentosa.
Sufferers experience chronic congestion from repeatedly taking the medication, which they feel can only be relieved by using more of the product.
Rebound congestion can also cause damage to tissues inside the nose, according to the MHRA.
The change will see all new packaging and leaflets for the products stating the five-day limit on use, changed from the previous limit of seven days.
In a press release on April 30, the MHRA said it had taken the step “in line with advice from Expert Advisory Groups to the Commission on Human Medicines due to adverse effects following prolonged use”.
In January, research by Ipsos and ITV News revealed more than a fifth of adults who have used these products have done so for longer than seven days.
This means an estimated 5.5 million people in the UK could have risked developing a dependency to nasal sprays containing xylometazoline and oxymetazoline.
Following our first report into the issue, ITV News received thousands of comments and emails from those who had suffered the effects of rebound congestion – some, for decades.
Rebound congestion is also known as rhinitis medicamentosa. Credit: iStock
We heard reports of problems with sleep, anxiety, intense congestion and headaches when attempting to stop using these types of nasal sprays.
In rare cases, some even undergo surgery to alleviate the effects.
Thao Huynh, Head of Respiratory Imaging and Critical Care at the MHRA, said: “If your nose is still blocked after five days of using a nasal spray, it could be caused by overuse of the product, rather than your original symptoms.
“Continuing to use it could make the problem worse. Instead, talk to a healthcare professional about stopping use of the product and whether alternative treatments could help.
“These nasal sprays are safe and effective treatments when used as directed. It is important to always read the Patient Information Leaflet that comes with your medicine and information on the outer packaging.”
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The Royal College of Pharmacy said it welcomed the move, after having previously called for a change in labelling.
Professor Amira Guirguis, chief scientist at the organisation, said: “We support clearer product information and improved packaging, alongside consistent public messaging, to improve awareness that these products are for short-term use only and to avoid preventable harm.
“Pharmacists play a key role in supporting patients to use them safely and advising on safer alternatives where appropriate.”
Suspected side effects associated with xylometazoline and oxymetazoline can be reported to the MHRA through its Yellow Card scheme.
If you have any concerns, contact your GP.
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