Topical steroids: New drug safety update from MHRA

Topical steroids: New drug safety update from MHRA

Overview

The MHRA has today released a drug safety update on the possibility of severe side effects with topical steroids. 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.

  • mildly potent (for example, hydrocortisone)
  • moderately potent (for example, clobetasone)
  • potent (for example, betamethasone)
  • very potent (for example, clobetasol).

The lowest potency topical steroid for effective treatment should be used and this may mean using different potency products for different body areas.

Advice for healthcare professionals:

  • Adverse reactions have been reported following long-term (generally 6 months or more) use of moderate or stronger potency topical steroids, particularly when used for eczema treatment – these reactions are often referred to as ‘Topical Steroid Withdrawal Reactions’ (TSW)
  • Symptoms of TSW can include intense redness, stinging, and burning of the skin that can spread beyond the initial treatment area
  • The risk of these and other serious reactions increases with prolonged use of higher potency steroid products
  • Over the coming year, topical steroids will be labelled with information on their potency to assist with counselling patients
  • When prescribing or dispensing topical steroids, advise on the amount of product to apply, how often, where to apply it and when to stop treatment
  • If previous discontinuation was associated with reactions that raise suspicion of TSW, alternative treatments should be considered
  • Provide support to patients living with symptoms of TSW and review treatment plans with patients
  • Report suspected adverse drug reactions to the Yellow Card scheme, including after discontinuation of topical steroids

Advice for healthcare professionals to provide to patients and carers:

  • Cases of skin reactions have been reported by long-term users of topical steroids when stopping treatment, including intense redness, stinging, and burning of the skin that can spread beyond the initial treatment area (see Patient Safety Leaflet on topical corticosteroids and withdrawal reactions)
  • The exact frequency cannot be determined but the reactions are estimated to be rare
  • If using more than one topical steroid on different body areas, ensure you are using the correct strength for the area of the body concerned. In the future the strength will be displayed on the packaging of your medicine
  • Seek medical advice before using a topical steroid on a new body area as some areas may require a different topical steroid
  • Always apply topical steroids as instructed and read the Patient Information Leaflet provided with your medicine
  • Ask your prescriber or pharmacist if you have any questions about your medicines or are concerned about side effects – and report suspected side effects to the Yellow Card scheme

Further details of the drug safety update are available here. Other update of relevance to pharmacy professionals in general practice may be found here.


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M Moyo

Founder of GP Pharmacy Club. Clinical Pharmacist working in GP Primary Care. Experienced community pharmacist. Independent Prescriber.

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