12 March 2025
Updates to potency labelling for topical corticosteroids
The MHRA has implemented new potency labelling requirements for topical corticosteroid preparations so that they will all be labelled on the container, packaging, and patient information leaflet with a potency: mild, moderate, strong, or very strong. When used correctly, topical corticosteroids are a safe and effective treatment; however, severe adverse effects have been reported, rarely, on stopping treatment, often after long-term continuous or inappropriate use of moderate to high potency preparations. The new potency labelling aims to help patients use products appropriately and make it easier for clinicians to provide clear advice on how to use preparations, particularly when patients are using more than one topical corticosteroid on different body areas. See 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.
As a result of these regulatory changes, we undertook a review of the potency statements for topical corticosteroids in BNF and BNF for Children. Our review found that most topical corticosteroid potencies in BNF were in line with those in licensed product information (Summary of Product Characteristics or SmPC: an important source of information for drugs in BNF). However, variations between BNF and licensed product information may occur due to consideration of additional sources and advice from expert groups, and we did identify a few long-standing differences. The potency for fludroxycortide in BNF differed (moderate in BNF; potent in SmPCs). In addition, as BNF had historically considered the formulation as well as the corticosteroid when assigning potencies, the potencies for diluted formulations of betamethasone and fluocinolone acetonide in BNF were classed as moderate, whereas the undiluted formulations of these drugs were classed as potent. Our review also found that the potency for hydrocortisone butyrate was updated in the SmPC from potent, which had been reflected in BNF, to moderate, in 2024.
We discussed the new potency labelling with the BNF expert dermatology advisory group, and the advisers were supportive of changes which would make labelling clearer for patients. We therefore decided that potencies in BNF and BNF for Children should be aligned with the MHRA’s potency labelling to support clear and consistent messaging about potencies, and to mitigate the risk of confusion which could occur if there were differences in potencies between BNF and product literature. This update was published for the November 2024 update of the online versions of BNF and BNFC and the BNF + BNFC app, and was reported as a significant change in the Changes section of online versions and in the BNF newsletter. It will also be in the next print editions: BNF 89 (March – September 2025) and BNF for Children (2025-2026). See the treatment review for Topical corticosteroids, as well as potency statements and Important safety information in individual drug monographs e.g. hydrocortisone butyrate.
