On February 15, 2005 the US Food and Drug Administration (FDA) Pediatric Advisory Committee recommended a “black box” warning be placed on topical calcineurin inhibitor (Elidel® – pimecrolimus and Protopic® – tacrolimus), followed by the FDA issuing a Public Health Advisory on March 10, 2005 regarding the safety concerns.

See the resources below to read statements regarding the FDA’s black box warning:

  • American Academy of Dermatology (AAD)
  • Canadian Dermatology Association (CDA)
  • National Eczema Association for Science and Education (NEASE)
  • Inflammatory Skin Disease Institute