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Dermal Tacrolimus for « Prevention » (Protopic )
Atopique Eczema – a treatment to avoid
Cancer Warning, especially for long-term use
To relieve patients with atopic eczema, the risk-benefit balance of dermal tacrolimus is decidedly
unfavourable (1). Yet, it has now been authorised for the long-term prevention of new flares, with an
application once a day, two days a week.
This new indication is based on two randomized double blind placebo controlled trials for the
treatment of flares, on a total of 306 patients who had earlier responded to tacrolimus. With the
extension of treatment up to one year, 50% of patients taking tacrolimus had no new flares, as against
20% with the placebo(2). There was no comparison with topical corticosteroids.
Dermal tacrolimus carries a risk of frequent irritation and skin infections (folliculitis, herpes,
impetigo, etc)(2). Cases of lymphoma, cutaneous and otherwise, have also been reported (2,3).
The risk of a systemic effect of this immunosuppressant is also a cause of concern (1).
The use of dermal tacrolimus should be banned for short term treatment, and even more so for the
long term. In atopic eczema, it is best to avoid irritants, to apply emollients over time and to use
corticosteroids cautiously during flares (4).
Extracts from a Prescrire document search
When we asked Astellas they gave us only published documents.
1- Prescrire Rédaction “tacrolimus dermique-Protopic”. Trop d’inconnues pour utiliser cet
immunodepresseur par voie cutanée” Rev Prescrire 2003 ; 23 (245) : 805-809
2- Commission européenne « Resumé des caractéristiques du produit Protopic » 7avril2009 : 12
pages
3- Prescrire Rédaction « Tacrolimus topique : cancers (suite) Rev Prescrire 2003 ; 28(301) :828
4- Prescrire Rédaction « Idees-Forces Prescrire.Eczema atopique » mise à jour décembre 2007 ;
site www.prescrire.org: 7 pages.