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- Title
An Update on the Safety and Tolerability of Pimecrolimus Cream 1%: Evidence from Clinical Trials and Post-Marketing Surveillance.
- Authors
Langley, Richard G.B.; Luger, Thomas A.; Cork, Michael J.; Schneider, Dirk; Paul, Carle
- 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 afavourable 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. Copyright © 2007 S. Karger AG, Basel
- Publication
Dermatology (10188665), 2007, Vol 215, p27
- ISSN
1018-8665
- Publication type
Article
- DOI
10.1159/000102118