Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence.
Topical calcineurin inhibitors (pimecrolimus, Elidel, East Hanover, NJ; and tacrolimus, Protopic, Tokyo, Japan) have been approved for the use in atopic dermatitis since the year 2000. These compounds represent a relatively safe class of topical anti-inflammatory, nonsteroidal therapy. However, in January of 2006, the US Food and Drug Administration issued a black box warning on these compounds about possible concerns of increased long-term malignancy risk due to systemic immunosuppression. To date, studies from clinical trials, systemic absorption, and post-marketing surveillance show no evidence for this systemic immunosuppression or increased risk for any malignancy.
Spergel
Jonathan M
JM
Leung
Donald Y M
DY
D065095:Calcineurin Inhibitors; D003876:Dermatitis, Atopic / Q000178:diet therapy*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000150:complications; D007165:Immunosuppression Therapy / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D009369:Neoplasms / Q000139:chemically induced / Q000209:etiology; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; D016559:Tacrolimus