Eczema drugs tacrolimus (Protopic) and pimecrolimus (Elidel): cancer concerns

Reason for posting: Many patients with eczema, or atopic dermatitis, are prescribed the topical immunomodulators tacrolimus and pimecrolimus. The drugs are often given to people for whom the potential side effects of topical corticosteroids (e.g., systemic absorption, skin thinning, telangiectasia) are a concern. However, the US Food and Drug Administration (FDA) recently reviewed the safety of these agents and warned that they may be associated with a risk of cancer.1 Causative associations are uncertain, but the FDA is also reporting the cases of several patients in whom cancer developed after drug use. For tacrolimus, 19 cases of cancer were reported, involving 16 adults and 3 children under the age of 16. The cancers were diagnosed 21-790 days after the start of therapy (the median time to diagnosis was 150 days). Nine cases involved lymphomas, and 10 involved skin tumours (7 at the site of the drug application). Tumour types included squamous cell carcinoma, cutaneous sarcoma and malignant melanoma. For pimecrolimus, 10 postmarketing cases of cancer were reported, involving 4 children (3 less than 6 years of age) and 6 adults. Of the 10 cases, 6 involved cutaneous tumours and 4 were lymphomas. Diagnoses were made 7-300 days after treatment was started (median time to diagnosis was 90 days). 1. US Food and Drug Administration. FDA Public Health Advisory: Elidel (pimecrolimus) cream and Protopic (tacrolimus) ointment. 2005 Mar 10. Available at: www.fda.gov/medwatch /SAFETY/2005/safety05.htm#Elidel (accessed 2005 Mar 30).