Case study: Steroids and red skin syndrome

Background information

A report was sent to the Yellow Card scheme about ‘red skin syndrome’.  To reduce the risk of these side effects, we reviewed all the evidence available, including Yellow Card reports and information published by researchers and other medicines regulators. 

Investigation

We assessed 55 reports and 62 possible reports in the Yellow Card database that were likely to be red skin syndrome reactions. Some of the cases were reported for a few steroids, as healthcare professionals may change the steroid type or strength to try and resolve the symptoms. 

Many of the names and terms describing the side effects in these reports were already known and listed in the product information.  This meant that it was harder to detect new safety concerns.  It also revealed this under-represented condition.  Many reports showed that patients found the information on red skin syndrome reactions themselves, instead of from a healthcare professional. 

Response

We took regulatory action by contacting the companies of the products to update the product information for all topical steroids. We also worked with experts and skin charities to develop wording for the patient information leaflet and to produce a separate leaflet to support the safe use of these medicines. To help raise awareness, the MHRA also sent  a Drug Safety Update article to healthcare professionals. 

Additional information

Topical corticosteroids are medicines that are applied directly to the skin to reduce inflammation and irritation. These side effects are also known as steroid addiction, topical steroid withdrawal, red burning skin, and steroid dermatitis. In this case study, we use the term red skin syndrome reactions.

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