Recommended use of some nasal decongestant sprays limited to five days by UK regulator

The Medicines and Healthcare products Regulatory Agency (MHRA) has limited the use of nasal decongestant sprays containing xylometazoline and oxymetazoline to a maximum of five days, in line with advice from Expert Advisory Groups to the Commission on Human Medicines due to adverse  effects following prolonged use.

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

Excessive use can cause rebound congestion, which is 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.

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

Changes in product information will take some months to be implemented. 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.

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.”

Professor Amira Guirguis, Chief Scientist at the Royal College of Pharmacy (RCPharm), said:

“The Royal College of Pharmacy welcomes this update on the safe use of nasal decongestants containing xylometazoline and oxymetazoline.

“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.”

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

Notes

• The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the maximum duration of use in response to recommendations from the Cardiovascular, Respiratory, Renal and Allergy Expert Advisory Group and the Pharmacovigilance Expert Advisory Group of the independent Commission on Human Medicines.
• The MHRA’s safety update is a result of evidence of side effects caused by overuse of products containing xylometazoline and oxymetazoline, rather than any concern about their quality.
• The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
• The MHRA is an executive agency of the Department of Health and Social Care.

SOURCE: GOV