Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially with prolonged use at high potency. In the coming months, as a result of regulatory action, topical steroid products will be labelled with information on their potency to simplify advice for patients, These will be labelled ‘mild steroid’, ‘moderate steroid’, ‘strong steroid’, and ‘very strong steroid’.
Serious side effects of topical steroid products
Whilst considered safe and effective, topical steroids can rarely lead to serious side effects such as thinning of the skin, adrenal suppression or very rarely Cushing’s syndrome, due to systemic absorption. The incidence of these more serious side effects is linked to the amount, potency and duration of use of the topical steroid, thinned skin appears translucent with visible tiny blood vessels and may be more fragile and more susceptible to stretch marks. This can be very difficult to see in brown or black skin, therefore careful monitoring is required. Adrenal suppression arises from overuse of topical steroids. The symptoms include low blood pressure, dizziness and fainting. This is a serious, life-threatening condition that needs urgent treatment. Stopping the topical steroid suddenly is dangerous if there is adrenal suppression, and it is likely that the individual will require oral steroid therapy replacement, cushing’s syndrome manifests with the development of a red, puffy, rounded face, acne and excessive facial and body hair, high blood pressure, weight gain, stretch marks, slow wound healing and frequent infections, patients, particularly those who require prolonged use or are using very potent topical steroids, should be advised to look for these effects and seek prompt medical attention if they occur. Please review adrenal crisis guidance and information from the Society of Endocrinology and National Patient Safety alert from NHS England for further advice, also in psoriasis, use of large quantities of topical steroids is associated with a risk of more severe disease such as generalised pustular psoriasis.
Review of Topical Steroid Withdrawal
Patients have also reported experiencing a less well understood group of side effects that has been termed Topical Steroid Withdrawal (TSW) reactions. TSW is the generally accepted patient-led term for these reactions - this group of conditions do not necessarily meet the medical pharmacological definition of withdrawal. The most commonly reported reactions include intense itching and burning, cycles of flaking skin, skin exfoliation and skin oozing. The reports also highlighted that the side effects experienced can be severe and patients require support as they can have a high psychological burden [footnote 3] (see Joint statement British Association of Dermatologists and National Eczema Society). We have also received a small number of Yellow Card reports that indicate a similar reaction can start whilst topical steroids are still being used. However, overall, the reactions reported to us have been more severe when associated with stopping treatment, Whilst these are still poorly understood groups of reactions, the evidence to date is that these reactions typically occur in four stages:[footnote 1],[footnote 2]
- A few days (usually) after discontinuation, there is an acute eruption of burning red, exudative skin which may extend to untreated areas
- Skin becomes dry and itchy with shedding (desquamation)
- Skin starts to recover but is more sensitive and intermittent flares may occur
- Skin recovers to the state prior to topical corticosteroid cessation. The recovery process may be prolonged
Since the last review of this issue in 2021 the MHRA have continued to receive reports and concerns from patients regarding TSW, also has carefully reviewed information received since the last review of this risk, and sought advice from the Commission on Human Medicines, during the review, data gathered from Yellow Card reports and the scientific literature was considered, there was little new information identified in the literature and limited information to help characterise or identify the causes of these reactions. As there is still no accepted clinical definition for these reactions, not all cases of adverse reactions reported via Yellow Cards as TSW will be true withdrawal reactions. Some of the reported cases may be due to the worsening of the underlying condition or other unidentified causes. However, undoubtedly the review did identify cases of adverse reactions, often severe, which were associated with the prolonged use of moderate or high potency steroids, Yellow Card reports up to August 2023 were reviewed and 267 reports were identified reporting reactions under the term TSW or with features that are often considered to be associated with this term.
Given the lack of new information in the scientific literature since the previous review, further research is required to fully understand the characteristics and reasons for these reactions, Also updated Patient Safety Leaflet for clinicians to use when discussing the risks and advice with patients, further information on TSW can be found in the September 2021 Drug Safety Update.
