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TCI "Black Box" warning among hot issues covered at 2005 DF Clinical


The DF Clinical Symposia presents current clinical topics in dermatology each year for review and discussion. The very successful 2005 symposia held in Amelia Island, Florida, from March 30-April 3, was no exception.

Among the topics presented this year was the first public discussion of the FDA Pediatric Advisory Board's February 15, 2005 recommendation of a "black box" warning for the previously approved topical calcinerin inhibitors (TCI) - tacrolimus (Protopic ) and pimecrolimus (Elidel ). TCI have provided a new class of dermatologic agents and have had a significant impact on the treatment of atopic dermatitis.

The panel leading the detailed analysis* was chaired by Dr. James Leyden (Professor of Dermatology, University of Pennsylvania) and included Drs. Richard Edelson (Professor and Chairman of Dermatology and Director of the Comprehensive Cancer Center of Yale University), Stuart Lessin (Director of Dermatology, Fox Chase Cancer Center) and Youn Kim (Professor of Dermatology, Stanford University). The panel concluded:

No new or previously reported human data demonstrated significant systemic absorption or sustained blood levels from dermal applications of TCIs in recommended indications and dosages.

Sporadic cases of systemic and cutaneous malignancies, particularly lymphomas, did not correlate with the types associated with immunosuppression and no new information suggested a causal relationship.

The vast majority of cutaneous T-cell lymphoma (CTCL) patients present after variable periods of "dermatitis", prior to the development of evident cutaneous lymphoma and experience and expertise is required to established the diagnosis of CTCL. Without evidence to the contrary, it is most likely that the reported cases of CTCL following TCI administration were undiagnosed CTCL from the onset of the "dermatitis".

A "black box" warning regarding use of TCI and a link to increased cancer risks is unwarranted.

Formal responses to the FDA by the professional academies (dermatology, pediatrics and allergy & immunology) will provide a more balanced dialogue in this matter.

For more information on this topic, go to the ACAAI web site search page and search for "calcinerin inhibitors", then select the link to the document titled, "Report of the Calcineurin Task Force of the ACAAI and AAAAI".

Further summaries of 2005 Clinical Symposia topics will be published in the Spring, Summer, and Fall issues of Dermatology Focus, a publication of the Dermatology Foundation.

Information of the 2006 Clinical Symposia to be held in Naples, Florida, from January 18-22 is provided below.

* The Dermatology Foundation holds no public opinion on the use of any product. Panel conclusions represent the individual opinions of the expert panelists. The DF Clinical Symposia is a forum for the discussion of current clinical issues impacting those in the field of dermatology.