MHRA Drug Safety Update: Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride

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

There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, referred to hereafter as ‘xylometazoline’ and ‘oxymetazoline’, wear off. This typically occurs when these medicines are used for longer than recommended. Continued use can also lead to more serious and longer-lasting changes to the lining and structures of the nose (rhinitis medicamentosa). In addition, repeated use will result in a rapid and noticeable reduction in the medicine’s effectiveness (tachyphylaxis).

Patients and caregivers should be informed not to exceed the recommended dose and not to use for more than 5 consecutive days. Continuous use of these medicines for more than 5 days can lead to an increased risk of side effects. Medical advice should be sought if symptoms of nasal congestion persist, worsen or do not improve after 5 days, as alternative treatment may be required.

Advice for Healthcare Professionals to Provide to Patients

• rebound congestion, rhinitis medicamentosa, and tachyphylaxis through overuse are recognised side effects with nasal sprays and drops containing xylometazoline or oxymetazoline when used beyond the maximum recommended duration
• patients may mistakenly interpret a rebound congestion effect as a continuation of the original congestion when it is a response to prolonged use of the product
• advise patients and their caregivers that xylometazoline and oxymetazoline are for short term use only and advise against prolonged or extended use beyond 5 days
• advise patients and their caregivers not to exceed the daily recommended dose and to take note of the minimum dosing interval stated in the product information
• if the symptoms of nasal congestion persist, worsen or do not improve after 5 days, alternative treatment may be required
• patients experiencing rebound congestion or related side effects may feel the need to continue using the products, leading to a cycle of overuse. Opportunistically review patients who may have become reliant on using these products and advise them on how to gradually stop using these medications. Stopping abruptly can worsen symptoms, but patients typically recover within 3 months with early recognition and treatment
• rhinitis medicamentosa is the most serious of these reported effects and is associated with persistent nasal congestion and longer-lasting changes to the nasal mucosa or structures of the nose. Symptoms may not resolve quickly after stopping the decongestant and, in severe cases, may require surgical intervention. Look out for patients presenting with severe nasal congestion and visible changes to the nasal mucosa or other internal nasal structures . Associated symptoms may include nasal irritation or itching, sneezing, and a runny nose. Management may require a tailored treatment plan, including gradual withdrawal of the decongestant, use of alternative therapies, and clinical follow-up to monitor recovery
• use of the nasal sprays or drops containing xylometazoline or oxymetazoline is contraindicated in patients who are taking other oral and nasal forms of sympathomimetic decongestants
• the product information will be transitioning over the next few months towards strengthened warnings regarding these side effects and to advise that they should not be used for more than 5 days
• report suspected adverse drug reactions associated with xylometazoline and oxymetazoline on a Yellow Card

Advice for Healthcare Professionals to Provide to Patients

• nasal sprays and drops containing xylometazoline and oxymetazoline are used to help clear a blocked nose, caused by cold, flu and allergies
• you can buy these medicines in shops and pharmacies without needing a prescription
• only use these medicines for a short time and to help with your symptoms. You should follow the instructions for use in the Patient Information Leaflet and package labelling which comes with the medicine and to not exceed the daily recommended dose and to take note of the minimum time interval between doses
• do not use these medicines for more than 5 consecutive days
• if you use these medicines for longer than the recommended duration, your nose may become blocked again, and you may get other problems such as runny nose, sneezing, itching and irritation on the inside of the nose or your body can stop responding to the medicine
• these side effects may make you feel like you need to keep using the medication to manage your symptoms – talk to a healthcare professional if you are having trouble stopping the medication, or are using for longer or more than recommended
• contact your doctor if your symptoms worsen or you do not feel better after 5 days, as you may need a different treatment
• do not use xylometazoline or oxymetazoline together or with other oral and nasal forms of medicines used to treat a blocked nose, such as pseudoephedrine, phenylephrine or ephedrine
• it is important to read the Patient Information Leaflet that comes with your medicine and information on the outer packaging and to talk to a healthcare professional if you experience side effects
• report suspected side effects associated with xylometazoline and oxymetazoline on a Yellow Card

For further details, please view the full Drug Safety Update here.