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Topical immunosuppressants:
increased risk of cancer

The negative benefit-harm balance of picrolimus and tacrolimus applied topically in the treatment of atopic dermatitis (alias atopical eczema) is confirmed by the onset of sometimes fatal cancers, including in children.

Picrolimus and tacrolimus, immunosuppressants sold in France to treat atopical eczema (or atopic dermatitis), have a negative benefit-harm balance. There is still a lot of uncertainty, in particular concerning infectious local adverse effects and the risk of interactions between these immunosuppressants and other drugs. The data collected by the USA Food and Drug Administration (FDA) show a worrying number of cancers linked to the topical use of picrolimus or tacrolimus, including in children. These observations are even more alarming since they confirm data from animal studies which showed an increase in the incidence of some cancers with these substances. These drugs serve as a reminder that topical application does not protect the patient from the general adverse effects of drugs: the skin is not a total barrier. The most effective prevention of these serious adverse effects is not to use these immunosuppressants, known to have a negative benefit-harm balance.

©Prescrire September 2005

Source: "Pimécrolimus ou tacrolimus dermique et cancers" Rev Prescrire 2005 ; 25 (264) : 592.

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