A Black-Box Warning for Tacrolimus and Pimecrolimus

Recently, the FDA mandated a “black-box” warning label for the topical nonsteroidal anti-inflammatory agents tacrolimus and pimecrolimus. The reasons for that decision, and the implications . . .

Recently, the FDA mandated a “black-box” warning label for the topical nonsteroidal anti-inflammatory agents tacrolimus and pimecrolimus. The reasons for that decision, and the implications for clinicians, are summarized below.

Background:

Tacrolimus ointment (Protopic 0.03, 0.1%) and pimecrolimus cream (Elidel 1%) are topical nonsteroidal anti-inflammatory agents indicated for atopic dermatitis in patients aged 2 years and older in whom conventional therapy is either ineffective or inadvisable because of concerns about adverse effects. (See JW Pediatr Adolesc Med Apr 12, 2004.) On March 10, 2005, the FDA, acting on concerns voiced by its Pediatric Advisory Committee that this class of drugs is associated with a theoretical risk for lymphoma,…

Author

Robert Sidbury, MD