American Academy of Dermatology Issues Statement Urging FDA Advisory Committees to Maintain Dermatologic Corticosteroids as Prescription Medications

SCHAUMBURG, Ill., March 23 /PRNewswire/ -- The American Academy of Dermatology (Academy) today issued a statement in response to a proposed change being considered by the U.S. Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee in which topical corticosteroids would be available to patients over-the-counter instead of by prescription.

"The American Academy of Dermatology is deeply concerned that if the FDA allows topical corticosteroids to be marketed over-the-counter instead of by prescription, patients could self-medicate without being monitored by their physician for serious side effects associated with long-term or improper steroid use," said dermatologist Clay J. Cockerell, M.D., president of the American Academy of Dermatology and the American Academy of Dermatology Association. "While weaker topical corticosteroids are available over-the- counter, we have seen some complications with their use. For the safety of patients, we urge the FDA to keep these stronger topical corticosteroids where they belong -- behind the pharmacy counter as prescription medications."

Topical corticosteroids -- which include prescription-strength cortisone creams - currently are prescribed by dermatologists and other physicians to safely treat a range of mild to severe skin conditions. Topical corticosteroids are relatively small molecules that penetrate the skin when applied topically, especially at higher concentrations, and can be absorbed in the bloodstream. The side effects that can occur from topical corticosteroid use include:

  -- Hypothalamic Pituitary Adrenal (HPA) axis suppression - Studies
     demonstrate that if sufficient topical corticosteroids are absorbed
     into the bloodstream, they can reduce the normal function of the
     adrenal glands that are responsible for producing the body's natural
     steroid hormones.  In some rare cases, this acute adrenal insufficiency
     can be life-threatening or lead to Cushing's syndrome -- a serious
     disease causing upper body obesity, weakened bones, and thinning of the
     skin which makes it fragile and susceptible to infection.
  -- Growth suppression -- Long-term systemic exposure to topical
     corticosteroids may result in slowed body growth and development, a
     special concern in children who have an increased risk of systemic
     exposure because of their higher ratio of skin to body volume.
  -- Adverse effects in the skin and eyes -- Inappropriate or overuse of
     topical corticosteroids can lead to obvious visible changes. The most
     common side effects of topical corticosteroid overuse include thinning
     of the skin, permanent stretch marks in body fold sites such as the arm
     pits and behind the knees, swelling of tiny blood vessels beneath the
     skin surface especially on the face, hypopigmentation and slowed wound
     healing.  Cataracts and glaucoma also could develop.

The purpose of the hearing is for the FDA advisory committees to address these potential side effects and how they can be monitored through a sufficient safety database in evaluating the prescription to over-the-counter switch of topical corticosteroids.

Tomorrow, dermatologist Sandra Read, M.D., of Washington, D.C., will speak on behalf of the American Academy of Dermatology Association at the FDA's joint advisory committee meeting. She will stress the importance of keeping topical corticosteroids as prescription medications.

"As well informed as patients can be, I do not believe that they should be self-diagnosing and self-treating symptoms with medications that have the potential for such serious side effects," said Dr. Read. "By removing the physician from the equation, you would be effectively eliminating a very important safeguard and protection for patients."

The American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. A sister organization to the Academy, the American Academy of Dermatology Association is the resource for government affairs, health policy and practice information for dermatologists, and plays a major role in formulating socioeconomic policies that can enhance the quality of dermatologic care. 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. For more information, contact the Academy at 1-888-462-DERM (3376) or http://www.aad.org/ .