Unboxing the black box on topical calcineurin inhibitors and cancer risk

Abstract

The topical calcineurin inhibitors, tacrolimus and pimecrolimus, are effective immunomodulators used in the management of moderate-to-severe atopic dermatitis. Topical tacrolimus ointment (0·03% and 0·1%) was approved by the US Food and Drug Administration (FDA) in 2000, and pimecrolimus cream (1%) in 2001, as second-line agents in children aged 2 years or older. However, in 2006, the FDA announced a black-box warning stating that the long-term safety of topical calcineurin inhibitors had not been established,1 citing post-marketing reports of increased risks of lymphoma and skin cancers in mainly isolated case reports, organ transplant recipients, and animal studies.