The topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus have been under suspicion for causing an increased risk of developing malignant lymphomas. Due to recent studies there is no clinical evidence of a connection between the use of TCIs and a decrease in systemic immonocompetence or increased risk for malignancy.
No risk of malignancy with TCIs
The clinical development programme for tacrolimus ointment includes more than 19 000 patients (including approximately 7600 children).
Worldwide more than 5.4 million prescriptions for tacrolimus ointment have been issued, with no evidence of an increased risk of malignancy in adults or children compared with the general population.
Similarly, epidemiological studies have not demonstrated any increase in the incidence of skin cancer in patients using TCIs, and no association has been shown between TCIs and a decrease in immunocompetence in the skin, nor any increase in the incidence of infections with long-term treatment.
Studies of the potential risk of malignancy with TCIs have shown, that the systemic absorption of tacrolimus when applied topically is very low
Adverse effects
Extensive clinical trials continue to show that tacrolimus ointment is well tolerated, and is generally an effective therapy for suitable patients with AD.
The most common adverse events (AEs) that occur with tacrolimus ointment treatment are transient application-site reactions, such as burning or pruritus. These complications are related to disease severity, and decrease in frequency over time as AD improves.
The incidence of nonapplication-site AEs does not increase with long-term treatment, and most such events occurring in clinical trials were considered to be unrelated to therapy.
Source: British Journal of Dermatology, 2007 November; 157 (5)
Published on www.pubmed.gov
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