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The introduction of the topical calcineurin inhibitors (<jats:styled-content style=\"fixed-case\">TCI<\/jats:styled-content>s), tacrolimus and pimecrolimus, more than 10\u00a0yr ago was a major breakthrough for the topical anti\u2010inflammatory treatment of <jats:styled-content style=\"fixed-case\">AD<\/jats:styled-content>. Pimecrolimus 1% is approved for second\u2010line use in children (\u22652\u00a0yr old) and adults with mild\u2010to\u2010moderate <jats:styled-content style=\"fixed-case\">AD<\/jats:styled-content>. The age restriction was emphasized in a boxed warning added by the <jats:styled-content style=\"fixed-case\">FDA<\/jats:styled-content> in January 2006, which also highlights the lack of long\u2010term safety data and the theoretical risk of skin malignancy and lymphoma. Since then, pimecrolimus has been extensively investigated in short\u2010 and long\u2010term studies including over 4000 infants (&lt;2\u00a0yr old). These studies showed that pimecrolimus effectively treats <jats:styled-content style=\"fixed-case\">AD<\/jats:styled-content> in infants, with sustained improvement with long\u2010term intermittent use. Unlike topical corticosteroids, long\u2010term <jats:styled-content style=\"fixed-case\">TCI<\/jats:styled-content> use does not carry the risks of skin atrophy, impaired epidermal barrier function or enhanced percutaneous absorption, and so is suitable for <jats:styled-content style=\"fixed-case\">AD<\/jats:styled-content> treatment especially in sensitive skin areas. Most importantly, the studies of pimecrolimus in infants provided no evidence for systemic immunosuppression, and a comprehensive body of evidence from clinical studies, post\u2010marketing surveillance and epidemiological investigations does not support potential safety concerns. In conclusion, the authors consider that the labelling restrictions regarding the use of pimecrolimus in infants are no longer justified and recommend that the validity of the boxed warning for <jats:styled-content style=\"fixed-case\">TCI<\/jats:styled-content>s should be reconsidered.<\/jats:p>","DOI":"10.1111\/pai.12331","type":"journal-article","created":{"date-parts":[[2015,1,3]],"date-time":"2015-01-03T07:49:14Z","timestamp":1420271354000},"page":"306-315","source":"Crossref","is-referenced-by-count":81,"title":["Pimecrolimus in atopic dermatitis: Consensus on safety and the need to allow use in infants"],"prefix":"10.1111","volume":"26","author":[{"given":"Thomas","family":"Luger","sequence":"first","affiliation":[{"name":"Department of Dermatology University of M\u00fcnster M\u00fcnster Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Boguniewicz","sequence":"additional","affiliation":[{"name":"Division of Pediatric Allergy\u2010Immunology Department of Pediatrics National Jewish Health and University of Colorado School of Medicine Denver CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Warner","family":"Carr","sequence":"additional","affiliation":[{"name":"Southern California Research Mission Viejo CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Cork","sequence":"additional","affiliation":[{"name":"Academic Unit of Dermatology Research Department of Infection and Immunity The University of Sheffield K Floor The Medical School (RHH Tower) Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mette","family":"Deleuran","sequence":"additional","affiliation":[{"name":"Department of Dermatology Aarhus University Hospital Aarhus C Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Eichenfield","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics and Medicine University of California San Diego School of Medicine Rady Children's Hospital San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Eigenmann","sequence":"additional","affiliation":[{"name":"Pediatric Allergy Unit Children's University Hospital Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regina","family":"F\u00f6lster\u2010Holst","sequence":"additional","affiliation":[{"name":"Department of Dermatology University Clinics of Schleswig\u2010Holstein Kiel Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Gelmetti","sequence":"additional","affiliation":[{"name":"Department of Pathophysiology and Transplantation University of Milan Clinica Dermatologica Fondazione I.R.C.C.S. 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