Nasal decongestant spray use limited to a maximum of five days by MHRA

The use of nasal decongestant sprays containing xylometazoline and oxymetazoline has been reduced from a maximum of seven to five days by the Medicines and Healthcare products Regulatory Agency (MHRA).

This decision was made in line with advice from expert advisory groups, including the Royal College of Pharmacy (RCPharm), to the Commission on Human Medicines due to adverse effects following prolonged use.

Professor Amira Guirguis, chief scientist at the RCPharm, said that they welcome ‘this update on the safe use of nasal decongestants containing xylometazoline and oxymetazoline.

‘Our recent survey found that almost 60% of pharmacists who responded believe patients are unaware of the risks of using these medicines longer than recommended.

‘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,’ said Professor Guirguis.

Nasal sprays and drops containing xylometazoline and oxymetazoline are typically used to help clear a blocked nose caused by cold, flu and allergies. They can be bought from shops and pharmacies without a prescription.

There have been reports of worsening nasal congestion – rebound congestion – when the effects of these nasal decongestant sprays or drops wear off, and this predominantly occurs when they’re used for longer than recommended.

This rebound congestion is associated with a temporary swelling inside the nose that can lead to a chronic condition called rhinitis medicamentosa, which causes severe nasal congestion and damage to tissues.

Additionally, repeated use can result in a rapid and noticeable reduction in the medicine’s effectiveness.

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.’

Nevertheless, Ms Huynh also emphasised that ‘these nasal sprays are safe and effective treatments when used as directed.’

In future, all new packaging and leaflets inside packs of sprays and drops containing xylometazoline and oxymetazoline will state the duration of use is not to exceed five days.

Furthermore, the wording of the leaflets will also be strengthened to emphasise the risks associated with prolonged use.

However, the MHRA states that changes in product information will take some months to be implemented and shops will continue to sell existing stock of nasal decongestants with packaging that states that they can be used for up to seven days.

Patients are advised to reduce their risks of side effects by following the updated guidance that limits the use of these products to five days.

Professor Guirguis added: ‘Pharmacists play a key role in supporting patients to use [these medications] safely and advising on safer alternatives where appropriate.’

As with all medicines, suspected side effects associated with xylometazoline and oxymetazoline can be reported to the MHRA through the Yellow Card scheme.