The U.S. Food and Drug Administration (FDA) warned doctors and consumers about the risk of an acne drug called Accutane. The pharmaceutical company that markets the drug had been tooting Accutane as a “cure” for acne. However, there have been reports that the drug may cause severe side effects such as depression, psychosis, suicidal thoughts, and actions.

The FDA admitted that reports of such severe psychological side effects have been known about for more than a decade.

The warning was included in the labeling but was hidden away in the complex “warning section” of the full drug information sheet given to doctors. The manufacturer of the drug says information about depression was taken off the label, where patients could see it and put in a separate sheet because “it captures the attention of physicians more readily.” If a doctor doesn’t warn the patient, there is no way for the patients to know of the possible devastating effects.

Despite the increasing awareness of the dangers associated with the use of Accutane, the manufacturer, Roche Laboratories, has tried to claim that the teens were depressed and killed themselves because of bad complexions. However, research has shown that in a number of patients the depression subsided when they stopped using Accutaneand returned when they resumed use.

The increased media attention to the danger of Accutane forced the FDA to recommend to Roche that the drug’s labels include information on the risk of using it.

SOURCE: “Important New Safety Information about Accutane,” Food and Drug Administration, Feb. 25, 1998; “Side Effects Prompt Stronger Warning on Acne Drug,” FDA Consumer, May-June 1998.