Safety of topical calcineurin inhibitors for the treatment of atopic dermatitis

Pharmacotherapy. 2007 Jul;27(7):1020-8. doi: 10.1592/phco.27.7.1020.

Abstract

Atopic dermatitis is a chronic, highly pruritic, and frequently recurring inflammatory skin disease that can be burdensome to affected individuals as well as to their family members, the health care system, and society as a whole. Immunomodulatory agents, such as topical corticosteroids and topical calcineurin inhibitors (TCIs), target the underlying immunopathology of atopic dermatitis and are the foundation of pharmacologic treatment for disease exacerbations. Recent recommendations from the United States Food and Drug Administration prompted the addition of a black-box warning and medication guide for tacrolimus ointment and pimecrolimus cream (both TCIs). The recommendations were based on a theoretical risk of malignancy derived from safety profiles, animal data, and reported cases of malignancy from clinical trials and postmarketing safety surveillance of oral calcineurin inhibitors. We know of no data that suggest that TCI use increases the risk of malignancy. Several dermatologic associations have issued statements supporting the safety of TCIs, and independent oncology experts have concluded that reported lymphomas were not related to TCI use. The black-box warning added to the TCI prescribing information also states that no causal link has been established. Effective treatment of atopic dermatitis can help alleviate the burden this disease imposes, and TCIs remain important treatment options.

Publication types

  • Review

MeSH terms

  • Animals
  • Calcineurin Inhibitors*
  • Clinical Trials as Topic
  • Dermatitis, Atopic / drug therapy*
  • Dermatitis, Atopic / metabolism
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / pharmacokinetics
  • Dermatologic Agents / therapeutic use*
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / therapeutic use
  • Lymphoma / etiology
  • Product Surveillance, Postmarketing
  • Tacrolimus / adverse effects
  • Tacrolimus / analogs & derivatives
  • Tacrolimus / pharmacokinetics
  • Tacrolimus / therapeutic use

Substances

  • Calcineurin Inhibitors
  • Dermatologic Agents
  • Immunosuppressive Agents
  • pimecrolimus
  • Tacrolimus