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The U.S. Food and Drug Administration issued a warning February 25 that the popular prescription acne drug Accutane (isotretinoin) has been linked to depression in a minority of patients.
Although the drug's label already includes a warning about depression as a possible adverse reaction, Accutane maker Hoffman-La Roche announced it was strengthening the labeling to reflect the reports received by the FDA. The new labeling does not imply a cause-and-effect relationship between Accutane and depression.
"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," said an FDA statement.
Since 1989 there have been 12 confirmed reports of people who developed depression after starting Accutane, experienced a remission when they stopped taking the drug, and suffered a recurrence when they resumed taking the drug, said FDA spokesperson Laura Bradbent. The safety alert is meant to heighten the awareness of physicians and patients but "should not be cause for great alarm," she added.
Kellie McLaughlin, a spokesperson for Hoffman-La Roche, said that psychiatrists receiving referrals from dermatologists should be aware of the reports. But she also noted that teenagers suffer a higher incidence of depression than adults and that those with severe acne are at even greater risk.
"A teen with this severe form of acne is at risk for depression," said McLaughlin, both because acne can have a devastating effect on self-esteem and because the hormonal fluctuations associated with acne may contribute to depression.
Accutane is indicated only for "severe, recalcitrant, nodular acne," for which it has proven highly effective, McLaughlin noted.
The drug, which was introduced in the U.S. in 1982, has been used by more than 8 million people worldwide. It is strictly contraindicated in pregnancy because it has been shown to increase the risk of birth defects.
Psychiatrists who believe they have observed an adverse reaction to Accutane should contact the FDA MedWatch at (800) FDA-1088 or Roche Laboratories at (800) 526-6367. Those seeking the latest safety information from MedWatch can find it on the Internet at