FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-9                       Print Media:          301-827-6242
Feb. 25, 1998               
                            Consumer Inquiries:   800-532-4440

IMPORTANT NEW SAFETY INFORMATION ABOUT ACCUTANE

FDA today 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 labeling 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.

In the event of Accutane-related adverse events, health care providers are urged to contact the manufacturer, Roche Laboratories at 1-800-526-6367 or FDA MedWatch at (phone) 1-800-FDA-1088, (fax) 1-800-FDA-0178 or (mail) FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852.

Consumers seeking the latest safety information about FDA-regulated medical products also can find it at http://www.fda.gov/medwatch/safety.htm on the MedWatch Website.

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