MHRA Drug Safety Update — topical steroids

On 29 May 2024, GPs received a Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update¹ announcing a forthcoming regulatory requirement for much clearer potency labelling of topical steroids (TCS) and reminding clinicians of the possibility of topical steroid withdrawal reactions (TSW), especially with prolonged use of high-potency TCS to treat eczema. This followed an earlier MHRA Drug Safety Update recommendation and a Public Assessment Report on TCS and TSW published on 2 and 15 September 2021, respectively.^2,3

Patients at risk with eczema may have repeat prescribing flags for TCS. Risk levels might be identifiable using Practice Lists and data on annual cumulative grams, potency levels, and length of time prescribed. Such patients may have had years of benefit from TCS use until their condition requires more frequent use of higher potencies to control recurrent flaring.⁴ The MHRA also states that some may stop using TCS after shorter periods of using ‘moderate or stronger potency’ TCS.¹ Some patients may stop adhering to dermatological guidance because of fear of TCS,⁵ and others may have purchased supplementary TCS from UK-regulated Care Quality Commission/General Pharmaceutical Council online pharmacies.⁶ Others may have symptoms that a recent dermatological joint statement highlighted as ‘conditions that could be mistaken for TSW’.⁷ Whatever the circumstances (and recognising extreme pressures on primary care),⁸ and given that GP practices treat the majority of patients with eczema, I am urging that patients at risk are identified and supported.

The MHRA update stated that there had been ‘little new information’ on TSW in the scientific literature or an ‘accepted clinical definition’ for these symptoms since their 2021 review.¹ Until scientific studies on TSW and long-term TCS use are prioritised by the dermatological research community, it is vital — when adverse reactions to TCS per se and/or when TSW symptoms are suspected¹ — for healthcare professionals and patients to submit Yellow Cards.