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FDA announces it is adding a "Black Box Warning Label on the eczema medications pimecrolimus (elidel) and tacrolimus (protopic). ISDI presented testimony at the FDA hearing on this issue. LaDonna's Testimony Ruthann's Testimony

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:

LaDonna Williams Testimony at FDA Hearing

I graduated from nursing school and specialized in pediatric nursing. I did clinical pediatrics for almost 7 years and then started having my own children – 3- as a matter of fact – 2 have full body eczema also known as atopic dermatitis. So I am here for 2 reasons – Chele and Zach.

Nothing, absolutely nothing in nursing school or the pediatric clinical arena prepared me for the disease atopic dermatitis. The pain, the rash, the chronic itching of the rash, infections and sleepless nights all took a toll on the entire family – with Chele and Zach only having to start a new day with the same rash, itch and pain as well as ridicule for their appearance. They heard names like “walking scab,” “disease girl,” and many more. They were not included in their peers’ social activities because of their appearance. They became withdrawn.

My children are older now and still fight the constant battle of atopic dermatitis. I am thankful for the topical immunomodulators like Elidel and Protopic. These drugs are the first treatment to offer my children an effective alternative to oral and topical steroids. We all are familiar with the adverse side effects of long term steroid use. My children have a better quality of life because topical immunomodulators provide effective relief from the constant itch and discomfort.

Other children deserve the same opportunity. I urge this committee to weigh all evidence very carefully before taking action.

Ruthann Newton Testimony at FDA Hearing

I’m Ruthann Newton, assistant director and support group coordinator of the Inflammatory Skin Disease Institute. ISDI is dedicated to improving the lives of people with skin disorders. We are a not-for-profit organization and we are supported by private and corporate grants including Novartis and Fujisawa.

Inflammatory skin diseases affect men, women and children of all ages and races. As you know, one of these inflammatory skin diseases is atopic dermatitis and that is why I am here today.

Most people may think of atopic dermatitis as a little rash behind knee or on the elbow. When in fact it can be a devastating serious medical health complication for some. These are the people I work with at ISDI, providing education, awareness and patient advocacy. Our support groups offer an opportunity to communicate with others. It is through the support groups that I am familiar with Elidel and Protopic topical immunomodulators, the two newest non steroidal treatments for patients who suffer with atopic dermatitis. Not only have I heard about the improvement in their atopic dermatitis – I have seen it.

Elidel and Protopic have not only provided relief and a better quality of life for the patients; it has provided relief to the whole family. There is no cure for atopic dermatitis. At this point the topical immunomodulators Elidel and Protopic are the best treatment alternatives to the oral and topical steroids.

Please consider the value of these new treatments. Consider the potential impact of a “black box” warning. It is my fear that this could set treatment back decades. A “black box” warning could take something away from patients that has given them success in the treatment and control of their Atopic dermatitis. Elidel and Protopic are improving the lives of people with skin disease.

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