Benefits outweigh risks in treatment of depressed youth

March 6, 2006

Controversy continues to surround the treatment of depressed youth. In 2004, the Food & Drug Administration ordered black box warnings for antidepressants, saying the drugs may increase the risk of pediatric suicidal thinking and behavior. But several recent studies conclude that not treating may be a worse threat and that black box warnings could be inhibiting treatment.

"Adolescent depression is common and potentially lethal," said Tracy Richmond, M.D., division of adolescent medicine at Children's Hospital in Boston. "Studies of antidepressant use in adolescents have demonstrated variable efficacy and an increased risk of suicidality. But in an adolescent with depression, there is risk in doing nothing."

The Substance Abuse & Mental Health Services Administration reports that in 2005 about 2.2 million adolescents-nearly one in 10-suffered at least one major depressive episode. Depression-related suicide is the third-leading cause of death among young people aged 15-24, according to the Centers for Disease Control & Prevention. Self-inflicted injury caused 4,010 such deaths in 2002, the latest year for which CDC data are available. Mental illness, including major depression and bipolar disorder, was present in more than 90% of those cases, according to a review of psychological autopsy studies by the American College of Neuropsychopharmacology (ACNP).

"The need is urgent for effective antidepressant treatments," said John Mann, M.D., chief, department of neuroscience at New York State Psychiatric Institute at Columbia University Medical Center. He chaired an ACNP task force on the effectiveness and safety of adolescent antidepressant use. "We are concerned that the FDA warning, however well intended, may be misinterpreted and doctors may choose not to treat youth with major depression," he said. "All treatments have risks and benefits, and these must be weighed against the option of no treatment. The first question is that of benefit."

In 2005, the American Psychiatric Association (APA) and the American Academy of Child & Adolescent Psychiatry (AACAP) wrote jointly to the FDA expressing concern that the black box warning mandated in 2004 caused a "swift and steep" decline in antidepressant use for young people. The letter said the prescribing rate fell 20% after the warnings; it called on the agency to study the issue further.

"We want to know the effect of the warning on prescribing patterns and how changes in prescribing may affect actions of patients to harm themselves," said AACAP president Richard Sarles, M.D. "Our concern is whether depressed adolescents and children no longer taking these medications are receiving any care at all."

Awareness of the issues surrounding adolescent use of antidepressants is part of effective pharmaceutical care, said Glen Stimmel, Pharm.D., a professor at the USC School of Pharmacy. "Treatment of depression has become a responsibility of clinicians in all healthcare settings. Success requires knowledge, careful monitoring, and fine-tuning of pharmacotherapy across the continuum."