Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to (a) improve recognition of topical steroid withdrawal and (b) ensure that NHS clinicians are able to diagnose that condition accurately.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed topical steroid withdrawal (TSW) reactions and first communicated about these reactions in September 2021 through our Drug Safety Update (DSU), which is widely disseminated among health care professionals. This communication can be found at the following link:

www.gov.uk/drug-safety-update/topical-corticosteroids-information-on-the-risk-of-topical-steroid-withdrawal-reactions

The MHRA had continued to monitor reports of TSW reactions and undertook a further review in 2024, resulting in an additional DSU publication which can be found at the following link:

www.gov.uk/drug-safety-update/topical-steroids-introduction-of-new-labelling-and-a-reminder-of-the-possibility-of-severe-side-effects-including-topical-steroid-withdrawal-reactions

During this review advice was sought from dermatologists, the National Eczema Society, and the Commission on Human Medicines. Consequently, the MHRA took forward a number of actions including ensuring there are updated warnings in the product information that is supplied with the creams, and the inclusion of information regarding the potency of topical steroids on the packaging. The British National Formulary (BNF) has updated their topical steroids potency information in line with the outcomes of the MHRA review. BNF treatment summary for topical corticosteroids, including information on withdrawal reactions, can be found at the following link:

https://bnf.nice.org.uk/treatment-summaries/topical-corticosteroids/

Furthermore, the MHRA engaged with the British Association of Dermatologists who have released an updated statement that can be found at the following link:

https://cdn.bad.org.uk/uploads/2024/02/22095550/Topical-Steroid-Withdrawal-Joint-Statement.pdf

Following these discussions, the British Association of Dermatologists has formed a Topical Steroid Withdrawal Working Party Group in collaboration with National Eczema Society, Scratch That, Primary Care Dermatology Society, and the British Dermatological Nursing Group. A Topical Steroid Withdrawal Joint Statement from the Topical Steroid Withdrawal Working Party Group is available at the following link:

https://www.bad.org.uk/topical-steroid-withdrawal-joint-statement

The objective of the TSW Working Party Group is to develop an expert consensus guidance on supporting people with concerns about TSW, including a Patient Information Leaflet, and any revision to the above joint statement, as appropriate.

The MHRA acknowledges that more high-quality research would enhance the understanding of TSW reactions, including what causes them and how to accurately diagnose and manage them. To make good decisions about what research to fund, the National Institute of Health and Care Research (NIHR) needs a balanced picture about which questions most urgently need answering. To achieve this, they ask patients, carers, clinicians, healthcare workers, service managers, and researchers for research topics. Any member of the public can submit suggestions via the NIHR website at the following link:

https://www.nihr.ac.uk/get-involved/suggest-a-research-topic

In the meantime, the MHRA continues to monitor reports of TSW reactions via the Yellow Card Scheme, which encourages anyone to report if they suspect an adverse reaction to a medical product or products. Access to the Yellow Card reporting site can be found at the following link:

https://yellowcard.mhra.gov.uk/

In addition to Yellow Card Scheme, the MHRA receives adverse event reports from pharmaceutical companies who collect data from healthcare professionals and patients, as well as cases from published literature and other sources.