MHRA Sets 5-Day Limit on OTC Nasal Decongestant Sprays

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced new safety guidance limiting the use of nasal decongestant sprays containing xylometazoline and oxymetazoline to a maximum of five days, following advice from expert advisory groups to the Commission on Human Medicines due to adverse effects from prolonged use. This marks a change from earlier instructions that allowed use for up to seven days.

Xylometazoline and oxymetazoline are topical α-adrenergic agonists that constrict nasal blood vessels and are commonly used to relieve nasal congestion caused by colds, flu, and allergies. These medicines are widely available over the counter in shops and pharmacies without a prescription and are frequently used for short-term relief of a blocked nose.

However, the MHRA has revised its guidance following expert advice, citing concerns about the risk of adverse effects like “rebound congestion” associated with prolonged use. Rebound congestion results from drug-induced vasodilation after prolonged vasoconstriction and can lead to a chronic condition called rhinitis medicamentosa, a condition of persistent nasal congestion caused by overuse of topical decongestants, which may also result in tissue damage.

To address these risks, the MHRA has instructed that all new packaging and patient information leaflets inside packs of sprays and drops containing xylometazoline and oxymetazoline will state that the duration of use must not exceed five days.

The wording of the leaflets will also be strengthened to emphasise the risks associated with prolonged use. However, the agency noted that it may take several months for these updates to appear on all products, and existing stock may still carry older instructions recommending use for up to seven days.

Patients are therefore advised to follow the updated guidance that limits the use of these products to five days. Recommendations may vary for children depending on product strength and formulation.

Officials, including Thao Huynh, Head of Respiratory Imaging and Critical Care at the MHRA, emphasise that while these sprays are safe and effective when used correctly, exceeding the recommended duration can worsen symptoms rather than relieve them. Patients are advised to speak to a healthcare professional about stopping use of the product and whether alternative treatments, such as saline sprays or intranasal corticosteroids where appropriate, could help.

The update has been welcomed by healthcare professionals, including representatives from the Royal College of Pharmacy, who support clearer product information and stronger public messaging. Pharmacists are expected to play a key role in helping patients use these medicines safely and in recommending appropriate alternatives when necessary.

Like all medications, any suspected side effects linked to xylometazoline and oxymetazoline can be submitted to the MHRA via the Yellow Card Scheme. The change is based on evidence linking prolonged use to adverse nasal effects rather than any concern about product quality.

Overall, the MHRA’s decision reflects a growing emphasis on patient safety and awareness while reinforcing the importance of appropriate use of over-the-counter medicines.

References

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

Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse