Statement Regarding FDA Decision On Two Eczema Medications By American Academy Of Dermatology

Main Category: Eczema / Psoriasis
Article Date: 11 Mar 2005 - 12:00 PDT

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The American Academy of Dermatology (Academy) today issued a statement in response to the U.S. Food and Drug Administration's (FDA) announcement that it is adding a black box warning to the health professional label for pimecrolimus and tacrolimus in addition to developing a medication guide for patients.

"The American Academy of Dermatology is disappointed that the FDA has taken this action, despite the fact that there is no data that proves proper topical use of pimecrolimus and tacrolimus is dangerous in people," said dermatologist Clay J. Cockerell, M.D., president of the American Academy of Dermatology. "Because these medications are applied to the skin, virtually none of it gets inside the body. It's not the same as taking a pill. These are valuable medications, and if used properly, they significantly reduce the debilitating impact of eczema and allow millions of our patients to live normal lives."

On February 15, 2005, dermatologist Robert A. Silverman, M.D., of Fairfax, Va., spoke on behalf of the Academy at an FDA pediatric advisory committee hearing, urging the FDA not to impose a black box warning or other labeling restrictions because such steps could limit access to these medications, or limit treatment options if qualified patients decide not to use these medications based on fear of a cancer risk.

Advocates representing eczema patients also spoke out against more restrictive labeling. "These medications have been the only treatments that have given my children anything resembling a normal quality of life," said LaDonna Williams, executive director, Inflammatory Skin Disease Institute (ISDI) and mother of two children with severe atopic dermatitis, which also is known as eczema. "Every day, we see first hand how these medications improve the lives of patients and their families," said Ruthann Newton, support group coordinator for the ISDI.

"The health, safety and welfare of our patients being treated with these topical medications are of paramount importance to dermatologists," said Dr. Cockerell. "We are concerned that these warnings will confuse and unnecessarily worry our patients. We urge patients to get the facts on how to appropriately manage their eczema from their dermatologist."

The American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 14,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or http://www.aad.org.

American Academy of Dermatology
http://www.aad.org