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Cave! Although Pimecrolimus is not genotoxic up to now, an FDA warning letter was published in March 2005: In animal experimental studies in mice it was shown that the topical application of Pimecrolimus can potentially lead to a reduction of the local immune response. Further studies ("repeat dose studies") in mice showed a dose- and therapy-dependent development of lymphomas. Dose-dependent carcinogenicity studies with perorally applied Pimecrolimus showed a dose- and therapy-dependent development of lymphomas and benign thymomas. Since 2006 the US-American product information carries a particularly emphasized warning notice (black box) in which the lack of knowledge about the long-term safety of the products regarding the development of skin cancer and lymphomas is explicitly pointed out.
- It is recommended:
- Use Pimecrolimus only according to the authorization in case of atopical eczema.
- Use Pimecrolimus as second-line therapy in case of ineffectiveness or intolerance of first-line therapies.
- Do not use Pimecrolimus in children < 2 years.
- Use Pimecrolimus only for a short time (as short as possible) and intermittently but not as a permanent therapy.
- Do not use Pimecrolimus in combination with UV-therapies.
- After market introduction of the drugs, the occurrence of lymphomas was observed in patients who were treated topically with calcineurin inhibitors and steroids. However, this could not be confirmed in a subsequent study.
- In the case of psoriasis inversa, clinical improvements after topical application of Pimecrolimus ( off-label-use) (see calcineurin inhibitors) showed in individual cases.
LiteratureThis section has been translated automatically.
- Arellano FM et al (2006) Risk of Lymphoma Following Exposure to Calcineurin Inhibitors and Topical Steroids in Patients with Atopic Dermatitis. J Invest Dermatol (epub)
- Eichenfield LF et al (2003) Elidel (pimecrolimus) cream 1%: a nonsteroidal topical agent for the treatment of atopic dermatitis. J Allergy Clin Immunol 111: 1153-1168
- Ortiz-Urda S, Rappersberger K (2003) New immunosuppressive agents for treating psoriasis. dermatologist 54: 230-236
- Rappersberger K (2002) Pimecrolimus identifies a common genomic anti-inflammatory profile, is clinically highly effective in psoriasis and is well tolerated. J Invest Dermatol 119: 876-887
- Ständer S et al (2003) Antipruritic effects of pimecrolimus and tacrolimus. dermatologist 54: 413-417
- Williams H (2002) New treatments for atopic dermatitis. BMY 324: 1533-1534
- Wohlrab J (2006) Calcineurin inhibitors for the topical therapy of psoriasis. dermatologist 57: 685-689
- Zabawski E (2002) Treatment of cutaneous lupus with Elidel. Dermatol Online J 8: 25