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. Our recent survey
found 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. 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
Cardscheme.
Notes to editors
- 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.
