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American Academy of Dermatology Issues Policy Statement On Accutane (Isotretinoin) SCHAUMBURG, IL -- November 30, 2000 -- In response to concerns over the safe use of a key treatment for severe cystic acne, the American Academy of Dermatology (AAD) recently issued a new policy statement on isotretinoin, also known as Accutane. Last month, an advisory panel to the Food and Drug Administration (FDA) heard testimony concerning isotretinoin and is considering placing it on a list of drugs that can only be obtained by registered physicians and patients. The AAD's new policy statement on isotretinoin, which indicates that patient safety is its primary concern, is as follows: -- The Academy is committed to the safe and responsible use of isotretinoin. -- The Academy calls on the FDA to not limit the ability of qualified patients, in consultation with their physician, to receive isotretinoin. -- The Academy supports more education for physicians and patients on potential pregnancy hazards. -- The Academy opposes the inclusion of isotretinoin on a list of drugs that can only be obtained by registered physicians and patients. -- The Academy calls for a study designed to determine if there is a direct causative link between isotretinoin and psychiatric events. -- The Academy calls upon the American Medical Association to support its efforts to insure the continued accessibility to, and medically appropriate use of, isotretinoin. The advisory panel's recommendation to the FDA stems from reports of depression and potential birth defects in women who may become pregnant while taking this medication. "The AAD's foremost concern is patient safety. While the AAD shares the FDA's concerns regarding the serious side effects of this powerful medication, it is crucial that patients for whom isotretinoin is the only effective choice for their severe, disfiguring acne be allowed to make that decision together with their dermatologist," said Richard K. Scher, M.D., President of the AAD. "Furthermore, the AAD supports education of physicians and patients -- a rather than regulation -- as the best way to ensure safe and effective results when using this medication," added Dr. Scher. "Limiting distribution of this important acne medication would severely restrict access to the drug, making it difficult to obtain, especially for patients in rural areas." E-mail this page to a friend or colleague! To print, use this version