MHRA flags risk of topical steroid withdrawal reactions

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Topical steroids are a go-to option for treating eczema and psoriasis. However, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has linked prolonged use to rare withdrawal reactions, leading it to call on manufacturers to update their labels.

The MHRA began reviewing the safety of topical steroids after a patient representative contacted it about the risk of withdrawal reactions. By reviewing the scientific literature and the U.K. database of adverse events, the MHRA identified evidence that patients have suffered topical steroid withdrawal reactions. The MHRA found 55 probable and 62 possible reports of reactions in its database.

That may underestimate how often the reactions occur. Most of the reports are from patients and use different terms to describe the reactions. The lack of consistent terminology, which the MHRA saw discussed in the scientific literature, could lead to the condition being under-represented. 

“A withdrawal reaction following long term use of these products can lead to skin redness and a burning sensation worse than the original skin condition. These reactions can be hard to distinguish from the original skin condition,” Alison Cave, Ph.D., chief safety officer at the MHRA, said in a statement.

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The evidence points to the reactions occurring after prolonged, frequent and inappropriate use of moderate to high-potency topical corticosteroids. Reactions have reportedly occurred after patients have used topical steroids at least once a day for more than one year.

Having identified the risk of withdrawal reactions, the MHRA has asked the holders of marketing authorizations for topical steroids to update their summaries of product characteristics and patient information leaflets. The MHRA has shared text about the risk of withdrawal reactions for companies to add to their materials.

The agency is also advising healthcare professionals to prescribe the lowest potency needed to treat the skin disorder and to consider reducing the strength or frequency of application in individuals who continue to use the treatment for a prolonged period of time.