Depression and Suicide in Patients Treated with Isotretinoin

Abstract
Between 1982 and May 2000, the Food and Drug Administration (FDA) received reports of 431 cases of depression, suicidal ideation, suicide attempts, or suicide in U.S. patients treated with isotretinoin (Accutane, Hoffmann–LaRoche), which is indicated for the treatment of severe nodular acne. There were 37 patients who committed suicide, 24 of them while using isotretinoin and 13 after ceasing to use it. Of these patients, 31 (84 percent) were male, and their median age was 17 years (range, 13 to 32). Among those still using the drug at the time of the suicide, the median duration of use was 3 months; for those who had stopped using it, the median interval between stopping the drug and committing suicide was 2.5 months. A history of psychiatric illness was reported for 8 of the 37 patients (22 percent). The median peak dose was 1.0 mg per kilogram of body weight per day (recommended range, 0.5 to 2.0 mg per kilogram per day).