When properly used, according to product labeling tacrolimus (protopic) and pimecromilus (elidel) are valuable medications to millions of patients, helping them lead normal itch-free lives.  These medications represent a medical breakthrough for patients with eczema/atopic dermatitis.  The March 10 Public Health Advisory posting by the FDA for a black box warning labeling has the potential to limit access and treatment options based on fear. The Pediatric Advisory Committee of the FDA made these recommendations despite the testimony of the Inflammatory Skin Disease Institute and the American Academy of Dermatology.  Clay Cockrell, MD, president of the AAD, response statement can be viewed at: 

http://www.aad.org/public/News/NewsReleases/fda_decision.htm

GET INVOLVED – it is not too late to express concerns to the FDA

Dr. Florence Houn
       FDA
       DHHS/FDA/CDER/OND/ODE3
       Supervisory Medical Officer
       Parklawn Building
       Room 13B45
       Mail Stop HFD-103
       Rockville, MD 20857
       email:  florence.houn@fda.hhs.gov
       Phone:  301-827-3144
       FAX:  301-480-3761

 KEY FACTS THAT MAYBE HELPFUL:

1.    Eczema is a chronic condition that affects an estimated 35 million Americans.  Eczema causes the skin to become dry, itchy and inflamed.  Children living with eczema often suffer through sleepless nights, itchy and burning skin and can face teasing at school.  Elidel and Protopic are the first alternative treatments to topical steroids.

2.    When used according to their approved labeling, Elidel and Protopic are valuable medications to millions of patients, helping them lead normal itch-free lives and experience an overall better quality of life.

3.    It is important that the public is aware that the basis for the FDA’s recommendation for this warning is a proposed theoretical risk of cancer in humans and not a proven risk substantiated by clinical data.  This theoretical concern stems from animal studies conducted with high doses of an experimental oral form of Elidel given over a long period of time, not the topical cream form used in humans.  Confusion has been created with people thinking that Elidel and Protopic cause cancer in humans, when in fact, that has not been proven.

 Stay involved.  Contact your local, state, and national representatives.  Educate them on how inflammatory skin disease affects men, women and children of all ages and races and can truly affect their quality of life.

Our brochure,
 “The FAQs About Eczema” will isnow available in Spanish. Please call ISDI if you would like a brochure.

Would you like to be added to our mailing list? 
Please call: 757-223-0795 or e-mail ExDirISDI@aol.com or RPNewtn@aol.com to receive ISDI’s quarterly newsletter, ISDInformation.   ISDI also has brochures on several inflammatory skin disorders, such as eczema, rosacea and acne – free of charge. 

Scholarships Available:
The Inflammatory Skin Disease Institute (ISDI) offers college scholarships for students with inflammatory skin disease.  For more information or an application, please contact ISDI at (757) 223-0795.