Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of Yellow Card reporting for capturing cases of Topical Steroid Withdrawal.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.

In 2021, the MHRA published a Public Assessment Report (PAR), reviewing the available evidence for topical steroid withdrawal (TSW) reactions, which can be found at the following link:

https://www.gov.uk/government/publications/topical-steroid-withdrawal-reactions-a-review-of-the-evidence

To inform this report, a comprehensive review of the available evidence was undertaken. This included an assessment of data from Yellow Card reports to identify suspected spontaneous cases of TSW reactions associated with topical corticosteroids on the Yellow Card database, as well as information from the published literature and other medicines regulators. The review considered whether regulatory action was required to minimise the risk of these events.

The PAR resulted in two Drug Safety Updates in 2021 and 2024 which aimed to raise awareness on the risk of TSW reactions and introduce new labelling. Both updates are available, respectively, at the following two links:

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

https://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

The MHRA uses the Medical Dictionary for Regulatory Activities (MedDRA) to code suspected adverse drug reactions reported by patients and healthcare professionals via the Yellow Card scheme. MedDRA is an international, clinically validated medical terminology used by regulatory authorities and the biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing safety monitoring. MedDRA is updated twice annually, and new terms can be proposed by any MedDRA users. Following the publication of the PAR, the term “Topical steroid withdrawal reaction” was added to MedDRA as a lower level term in version 24.1 and made available to users of the Yellow Card website in February 2022 as part of routine updates. This helps to ensure that more reports pertaining to TSW reactions are appropriately captured. The MHRA continues to closely monitor Yellow Card reports submitted for suspected TSW reactions.

The MHRA continues to engage with the British Association of Dermatologist who have also released a statement, which is available at the following link:

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