Missy Gough, [email protected](847) 240-1734

Karen Klickmann, [email protected](847) 240-1735

Jennifer Gale, [email protected](847) 240-1730

THE AMERICAN ACADEMY OF DERMATOLOGY SUPPORTS EDUCATION FOR PATIENTS USING ACCUTANE

Schaumburg, IL (October 5, 2000) - The American Academy of Dermatology (AAD) supports education, not regulation, of physicians and patients using Accutane to treat severe cystic acne. However, an advisory panel to the Food and Drug Administration (FDA) recently heard testimony concerning Accutane and is considering placing it on a list of drugs that can only be obtained by registered physicians and patients.

"As dermatologists, we strongly believe that limiting access to Accutane is a disservice to patients and erodes the patient/physician relationship," said Richard K. Scher, M.D., President of the AAD. "The FDA's limitation of it will severely affect the lives of tens of thousands of teenagers, men and women."

Last month, during hearings before the advisory panel on the risks of Accutane, testimony was given regarding the use of the drug during pregnancy and the possible psychological side effects such as depression and suicide.

"Depression is a common problem in adolescents with or without acne. The links between suicide or depression and Accutane are unclear," said Dr. Scher. "To our knowledge, studies addressing this issue are yet to be completed and/or made available in medical literature."

According to testimony presented during the hearing, there are several alternate risk factors that are more likely to be associated with depression and suicide than the use of Accutane.

"As dermatologists, we know that acne is a serious disease that takes a psychological toll on patients," said Dr. Scher. "Many acne patients report feeling insecure, inferior, maladjusted, and even depressed, especially those patients with severe cystic acne, which can only be treated by Accutane. Education, not regulation, is the key to safe use of this drug."

Another issue raised during the hearing included the precautions needed by women of childbearing age when taking this drug, including discussions on adequate forms of birth control and monthly pregnancy tests. Since isotretinoin may cause birth defects, women in this age group must take the utmost precautions to prevent pregnancy during this therapy.

Accutane is an extremely valuable treatment for the care of destructive cystic acne. Since the product's introduction in 1982, Accutane has proven to be the only medication that safely and effectively controls severe cystic acne, the most serious form of this skin disease.

The American Academy of Dermatology, founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership over 12,000 dermatologists worldwide, the Academy is committed to: advancing the science and art of medicine and surgery related to the skin; advocating high standards in clinical practice, education, and research in dermatology; supporting and enhancing patient care; and promoting a lifetime of healthier skin, hair, and nails. For more information, contact the AAD at 1-888-462-DERM or www.aad.org.

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