Case study: Corn plasters and skin ulceration

Background information

A podiatric physician (foot doctor) contacted the Medicines and Healthcare Regulatory Agency (MHRA) regarding concerns over medicated corn removal plasters (a medical device) that contained salicylic acid. Two patients who had healthy skin and had used these plasters went on to develop ulcers where they were applied on the skin. This started a review of submitted reports of this type of reaction to corn removal plasters in contact with healthy skin. 

Investigation

MHRA experts assessed seven reports about plasters containing salicylic acid, on the Yellow Card scheme database. These Yellow Card reports mainly showed suspected skin reactions. The pharmaceutical company was asked to review the safety of the product and provide a response to the MHRA. 

Response

MHRA assessed seven reports about salicylic acid-containing plasters, on the Yellow Card scheme database. These Yellow Card reports showed mainly suspected skin reactions. The pharmaceutical company was asked to review the safety of the product and provide a response to the MHRA. 

Result

This resulted in the following new wording for the product information leaflet “local irritation or dermatitis may occur if applied to normal healthy skin surrounding the corn. This may be controlled by temporarily discontinuing use and by carefully applying only to the corn when the treatment is restarted.” 

Additional information

A corn plaster is a medicated plaster that can sometimes contain Salicylic Acid to soften and add moisture the skin around the corn.   

Skin Ulceration is an ulcer is a break in the skin where the tissue under is visible.

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