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| |  FDA Reports Accutane May Be Linked To Depression, Suicide WASHINGTON, MD -- February 26, 1998 -- The United States Food and Drug Administration is advising consumers and health care providers of new safety information regarding the prescription anti-acne drug Accutane (isotretinoin) and isolated reports of depression, psychosis and rarely suicidal thoughts and actions. Accutane was approved in 1982 to treat only a very special type of acne -- severe nodular acne that has not responded to other therapies. Although the Accutane label already included information regarding depression as a possible adverse reaction, the agency felt health care providers and others needed additional information as a result of adverse event reports the agency has received. FDA and the drug manufacturer are strengthening this label warning, even though it is difficult to identify the exact cause of these problems. Such problems could already be more common among the patient populations likely to be on the drug. However, because some patients who reported depression also reported that the depression subsided when they stopped taking the drug and came back when they resumed taking it, the agency and the manufacturer felt the strengthened labelling was warranted as a precautionary measure. Given the complex nature of depression and suicidal conditions, the new label information will advise health care providers that merely discontinuing the drug may be insufficient to remedy these adverse events and that further evaluation may be needed.
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