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2.Vigilance, safety alerts and guidance

Press release

Long-term continual use of topical steroids linked to skin withdrawal side effects

The Medicines and Healthcare products Regulatory Agency (MHRA) is advising anyone experiencing skin redness or burning sensations after they have stopped using these creams or ointments to seek advice from their health professional before using these products again.

From:Medicines and Healthcare products Regulatory Agency
    15 September 2021

Patients using topical corticosteroid creams to treat conditions such as eczema or psoriasis are reminded to do so in accordance with advice from their healthcare professional, after a national review found that people using topical steroid for long-periods of time can suffer severe skin withdrawal symptoms.

Although this is very infrequent reaction, the Medicines and Healthcare products Regulatory Agency (MHRA) is advising anyone experiencing skin redness or burning sensations after they have stopped using these creams or ointments to seek advice from their health professional before using these products again.

Topical corticosteroids are medicines applied directly to the skin to treat conditions such as eczema or psoriasis. Patients can experience topical steroid withdrawal reactions after using these products at least daily for long periods of time. It is not unusual for skin conditions to flare up or return shortly after stopping topical corticosteroids. However, very infrequently, a severe type of topical steroid withdrawal reaction can occur, which may also be known as red skin syndrome or topical steroid addiction.

Signs of severe topical steroid withdrawal reactions include redness of the skin which can be a spectrum of pink to purple, or as darkening of the normal skin tone, depending on the skin tone of the individual. Other signs include burning or stinging, intense itching, peeling of the skin, or oozing open sores. These signs may occur days or weeks after stopping treatment and are known to occur after as little as 2 months of continuous treatment in children. Examples of topical steroids include beclometasone,betamethasone, clobetasol, hydrocortisone, mometasone, and triamcinolone.

Alison Cave, Chief Safety Officer of the MHRA said:

When used correctly, topical corticosteroids are a safe and effective treatment for conditions such as eczema and psoriasis.However, a withdrawal reaction following long term use of these products can lead to skin redness and a burning sensation worse than the original skin condition. These reactions can be hard to distinguish from the original skin condition.

Patients should follow their healthcare professional’s advice on where, how often and for how long to use topical corticosteroids. Patients experiencing symptoms after stopping their topical steroid treatment should contact a healthcare professional for guidance. We advise anyone experiencing potential withdrawal symptoms to speak to their healthcare professional before starting to use these products again. Suspected adverse side effects can be reported to us through the Yellow Card scheme.

Andrew Proctor, Chief Executive of National Eczema Society said:

Many children and adults rely on topical corticosteroids to manage eczema inflammation. As with other treatments though, they can have side-effects including after you stop using them. It’s very important people know how to use topical corticosteroids safely and effectively. We urge people who are affected to read the newly published patient safety leaflet and to speak to their doctor or other prescriber if they have questions and concerns.

To coincide with National Eczema Week the MHRA is publishing the outcome of a comprehensive national review, which included assessment of published clinical research, reported drug reactions and advice from skin charities and organisations. Product information for topical corticosteroids is being updated to include safety warnings on withdrawal reactions. We have developed a patient safety leaflet to support patients and health care professionals, which includes advice on how to reduce the risk of severe reactions.

Healthcare professionals should:

  • prescribe the lowest potency of topical corticosteroid needed to effectively treat the skin disorder
  • consider reducing the strength or frequency of application gradually if topical corticosteroids have been used for a prolonged time
  • make sure patients know how to use it safely and effectively, especially on sensitive areas
  • report all suspected adverse drug reactions to the Yellow Card scheme, including after discontinuation of topical corticosteroids

For further information on using topical corticosteroids safely please see the full Drug Safety Update article and Patient Safety Leaflet.

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プレスリリース 報道機関 公式発表



医薬品&ヘルスケア製品規制当局発表より 2921年9月15日公開

全国的な調査 national review を実施し、ステロイド外用薬を長期間使用している患者が重度の皮膚離脱症状を患う可能性があることが判明した結果、湿疹や乾癬などのような症状を治療するためにステロイド外用剤を使用している患者は、医療専門家からのアドバイスに従って以下を再認識するよう忠告します。




MHRAの最高安全責任者であるAlison Caveは、次のように述べています。

局所コルチコステロイドは、正しく使用された場合、湿疹や乾癬などの症状の安全で効果的な治療法です。 しかしながら、これらの製品を長期間使用した後に続く離脱反応は、元の皮膚の症状よりも悪い、皮膚の赤みや灼熱感につながる可能性があります。これらの反応は、元の皮膚の疾患と区別するのが難しい場合があります。

患者は、局所コルチコステロイドをどこで、どのくらいの頻度で、どのくらいの期間使用するかについて、医療専門家のアドバイスに従う必要があります。 ステロイド外用薬の治療を中止した後に症状が出た患者は、医療専門家に連絡をとって相談してください。離脱症状の可能性がある患者は誰しもが、これらの製品を再び使用する前に、医療専門家に相談することを助言します。疑わしい有害な副作用は、イエローカードスキーム Yellow Card scheme を通じて私たちに報告することができます。

国立湿疹協会の最高経営責任者であるAndrew Proctorは、次のように述べています。

多くの子供と大人が、湿疹の炎症を管理するために局所コルチコステロイドに依存しています。 ただし、他の治療法と同様に、使用を中止した後など、副作用が生じる可能性があります。 ステロイド外用薬を安全かつ効果的に使用する方法を知っていることは非常に重要です。 症状のある方々には、新しく発行された患者安全リーフレットを読み、質問や懸念がある場合は医師または他の処方者に相談することを強く奨励します。

全国湿疹週間に合わせて、MHRAは、公開された臨床研究の評価、報告された薬物反応、および皮膚の慈善団体や組織からのアドバイスを含む、包括的な全国レビューの結果を公開しています。 局所コルチコステロイドの製品情報は、離脱反応に関する安全上の警告を含むように更新されています。 私たちは、患者と医療専門家をサポートするための患者安全リーフレットを作成しました。これには、重度の反応のリスクを減らす方法に関するアドバイスが含まれています。


  • 皮膚障害を効果的に治療するために必要な局所コルチコステロイドは、最も効力の低いものを処方する。
  • 局所コルチコステロイドが長期間使用され続けている場合は、薬の強度または塗布の頻度を徐々に減らすことを検討してください。
  • 特に敏感な部位には、患者がそれを安全かつ効果的に使用する方法を知っていることを確認してください。
  • 局所コルチコステロイドの使用中止後を含め、すべての疑わしい副作用をイエローカードスキームに報告してください。

局所コルチコステロイドを安全に使用するための詳細については、完全な医薬品安全性アップデートDrug Safety Updateの記事と患者安全性リーフレットPatient Safety Leafletを参照してください。


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GOV. UK (Published 15 September 2021)

Safety leaflet on topical corticosteroids and withdrawal reactions