title: An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance.
abstract: In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has a favourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2-5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy.
authors.affiliation: Division of Dermatology, Department of Medicine, Dalhousie University, and Queen Elizabeth II Health Science Centre, Halifax, NS, Canada. richard.langley@dal.ca
authors.forename: Richard G B
authors.initials: RG
authors.lastname: Langley
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Luger
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Cork
authors.forename: Dirk
authors.initials: D
authors.lastname: Schneider
authors.forename: Carle
authors.initials: C
authors.lastname: Paul
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D065095:Calcineurin Inhibitors; D002986:Clinical Trials as Topic; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D009369:Neoplasms / Q000139:chemically induced*; D011358:Product Surveillance, Postmarketing; D012869:Skin Absorption; D012874:Skin Diseases, Infectious / Q000139:chemically induced*; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics
chemical_list: D065095:Calcineurin Inhibitors; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; C117268:pimecrolimus; D016559:Tacrolimus