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