Topical corticosteroids: information on the risk of topical steroid withdrawal reactions

Rarely, severe adverse effects can occur on stopping treatment with topical corticosteroids, often after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks of these events, prescribe the topical corticosteroid of lowest potency needed and ensure patients know how to use it safely and effectively.

From:
Medicines and Healthcare products Regulatory Agency
Published
15 September 2021
Therapeutic area:
Dermatology

Advice for healthcare professionals:

  • long-term continuous or inappropriate use of topical corticosteroids, particularly those of moderate to high potency, can result in the development of rebound flares after stopping treatment – there are reports of such flares taking the form of a dermatitis with intense redness, stinging, and burning that can spread beyond the initial treatment area
  • when prescribing a topical corticosteroid, consider the lowest potency needed
  • advise patients on the amount of product to be applied; underuse can prolong treatment duration
  • inform patients how long they should use a topical corticosteroid, especially on sensitive areas such as the face and genitals
  • inform patients to return for medical advice if their skin condition worsens while using topical corticosteroid, and advise them when it would be appropriate to re-treat without a consultation
  • for patients currently on long-term topical corticosteroid treatment, consider reducing potency or frequency of application (or both)
  • be vigilant for the signs and symptoms of topical steroid withdrawal reactions and review the position statement from the National Eczema Society and British Association of Dermatologists
  • report suspected adverse drug reactions to the Yellow Card scheme, including after discontinuation of topical corticosteroids

Advice to give to patients and carers:

  • topical corticosteroids are used on the skin to reduce inflammation; when used correctly, they are safe and effective treatments for skin disorders
  • always apply topical corticosteroids as instructed and consult the Patient Information Leaflet provided with your medicine
  • seek medical advice before using a topical corticosteroid on a new body area as some areas of the body are more prone to side effects
  • very infrequent cases of severe skin reactions have been reported in long-term users of topical corticosteroids after they stop using them (see Patient Safety Leaflet on topical steroid withdrawal reactions)
  • if your skin worsens within 2 weeks of stopping a topical corticosteroid, do not start treatment again without consulting your doctor, unless they have previously advised you should do so
  • as well as the known side effects associated with using too much of a topical corticosteroid or with using it for too long, remember that using too little can prolong treatment time and increase the risk of certain adverse effects
  • ask your prescriber or pharmacist if you have any questions about your medicines or are concerned about side effects – you can also report suspected side effects to the Yellow Card scheme

Background

Topical corticosteroids are safe and highly effective treatments for skin conditions such as eczema, psoriasis, and atopic dermatitis when used correctly. They are available in different potencies:

  • mildly potent (for example, hydrocortisone)
  • moderately potent (for example, clobetasone)
  • potent (for example, beclometasone)
  • very potent (for example, clobetasol)

The lowest potency topical corticosteroid for effective treatment should always be used and this may mean using different products for different areas to be treated. The BNF has a guide to potencies using propriety names to help identify the correct preparation.

Review of topical steroid withdrawal reactions

Topical steroid withdrawal reactions have been reported in some long-term users of topical corticosteroids after they stop use. [footnote 1][footnote 2][footnote 3][footnote 4] This is a mixed group of symptoms or conditions, often also referred to by patients as ‘red skin syndrome’ or ‘topical steroid addiction’.

A particularly severe type of topical steroid withdrawal reaction, with skin redness and burning worse than the original condition, is currently an under-recognised side effect of topical corticosteroid treatment. Patients report encountering difficulties with diagnosis, leading many to self-treat. However, topical steroid withdrawal reactions are now being recognised by experts in the field and there are treatment options, in addition to alternative treatment approaches for the underlying condition (see position statement from the National Eczema Society and British Association of Dermatologists)

Following concerns from patients and their families about topical steroid withdrawal reactions, the MHRA has conducted a review of the evidence and considered the need for regulatory action to minimise the risk of this side effect. We sought advice on our assessment from the Dermatology and Pharmacovigilance Expert Advisory Groups of the Commission on Human Medicines. Clinical experts in dermatology and representatives from dermatology charities were represented in these discussions.

During our review we considered data gathered from Yellow Card reports and identified 55 reports indicative of topical steroid withdrawal reactions, most of which were reported by patients. We also considered information available in the literature and from other regulators. We are unable to estimate the frequency of these reactions. However, given the number of patients who use topical corticosteroids, we understand reports of severe withdrawal reactions to be very infrequent.

We have made available a Public Assessment Report.

Information about the risks and characteristics of topical steroid withdrawal reactions will be added to the Summaries of Product Characteristics and the Patient Information Leaflets for topical corticosteroid medicines. While the Patient Information Leaflets are being updated, we are supplying an advice for patients on topical steroid withdrawal reactions leaflet for clinicians to use when discussing the risks and advice with patients.

Patient risk factors

Topical steroid withdrawal reactions are thought to occur after prolonged, frequent, or inappropriate use of moderate to high potency topical corticosteroids. Topical steroid withdrawal reactions can develop after application of a topical corticosteroid at least daily for longer than a year.[footnote 1][footnote 4][footnote 5][footnote 6] In children they can occur within as little as 2 months of daily use.[footnote 5] People with atopic dermatitis are thought to be most at risk of developing topical steroid withdrawal reactions. [footnote 1]

It has been reported that the signs and symptoms occur within days to weeks after discontinuation of long-term topical corticosteroid treatment.[footnote 5] They are most commonly seen after treatment of sensitive areas such as the face or genitals.

Characteristic signs of topical steroid withdrawal reactions

The most common reaction is a rebound (or flare) of the underlying skin disorder such as atopic dermatitis. However, patients have described a specific type of topical steroid withdrawal reaction in which skin redness extends beyond the initial area of treatment with burning or stinging and that is worse than the original condition. It can be difficult to distinguish a flare up of the skin disorder, which would benefit from further topical steroid treatment, and a topical steroid withdrawal reaction.

A topical steroid withdrawal reaction should be considered if:

  • burning rather than itch is the main symptom
  • redness* is confluent rather than patchy (which may not be so obvious in people with darker skin)
  • rash resembles atopic dermatitis but involves unusual sites and is ‘different’ to the skin condition that the patient has experienced before
  • there has been a history of continuous prolonged use of a moderate or high potency topical corticosteroid

*Redness can be a spectrum of pink, red, and purple, or subtle darkening of the existing skin colour, which can vary depending on the skin tone of the individual.

Skin biopsy is generally unhelpful to distinguish topical steroid withdrawal reactions from a flare of the underlying skin disorder because the histopathology overlaps.

If the patient’s skin condition fails to improve, before prescribing a more potent corticosteroid, consider possible diagnoses such as rosacea, peri-oral dermatitis, infection and allergy to the topical corticosteroid or other topical medications, including moisturisers or cosmetics. Patch testing may identify some cases of contact allergy. If a severe rebound of atopic dermatitis is suspected, review the guidance on alternative treatments.

Report suspected reactions on a Yellow Card

Please continue to report suspected adverse drug reactions to the Yellow Card scheme.

Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:

When reporting please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.

Report suspected side effects to medicines, vaccines or medical device and diagnostic adverse incidents used in coronavirus (COVID-19) using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app. See the MHRA website for the latest information on medicines and vaccines for COVID-19.

Article citation: Drug Safety Update volume 15, issue 2: September 2021: 1.

  1. Hajar T and others. A systematic review of topical corticosteroid withdrawal (‘steroid addiction’) in patients with atopic dermatitis and other dermatoses. Journal of the American Academy of Dermatology 2015: volume 72, pages 541 to 549. ↩ ↩2 ↩3

  2. Gust P and others. The role of delayed-delayed corticosteroid contact dermatitis in topical steroid withdrawal. Journal of the American Academy of Dermatology 2016: volume 74, e167. ↩

  3. Sheary B. Topical corticosteroid addiction and withdrawal – An overview for GPs. The Royal Australian College of General Practitioners 2016: volume 45, pages 386 to 388. ↩

  4. Sheary B. Steroid Withdrawal Effects Following Long-term Topical Corticosteroid Use. Dermatitis 2018: volume 29, pages 213 to 218. ↩ ↩2

  5. Juhasz M and others. Systematic Review Of The Topical Steroid Addiction And Topical Steroid Withdrawal Phenomenon In Children Diagnosed With Atopic Dermatitis And Treated With Topical Corticosteroids. Journal of the Dermatology Nurses’ Association 2017: volume 9, pages 233 to 240. ↩ ↩2 ↩3

  6. Rapaport MJ and others. Corticosteroid Addiction and Withdrawal in the Atopic: The Red Burning Skin Syndrome. Clinics in Dermatology 2003: volume 21, pages 201 to 214. ↩

Published 15 September 2021
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