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Posted 10/18/2004 12:00 AM
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Questions, answers on 'black box' labels
Parents of the more than 1 million kids in the USA who take antidepressants may have questions about the warnings of increased suicide risk that will accompany the drugs. USA TODAY'S Marilyn Elias asked mental health experts for some answers.

Q: Does this mean that children and teenagers on antidepressants should stop taking them?

A: Not necessarily. Parents should discuss any concerns with the child's doctor. If antidepressants are working, with no bad side effects, the benefits of taking medication might outweigh the risks. Major depression increases the risk of childhood suicide about twelvefold, according to federal figures. More than half of kids with this disease try to kill themselves, and about 7% do commit suicide. In the studies reviewed by the FDA, 2 in 100 children on antidepressants became more suicidal because of the pills. There were no suicides reported in the studies.

Q: In hearings last month, parents told the FDA that these pills had caused their children to kill themselves. But there were no suicides in antidepressant studies involving more than 4,600 children. How can this discrepancy be explained?

A: Researchers typically check children in such studies for harmful side effects. But parents whose children killed themselves often reported casual diagnoses of their children, with no warnings about possibly serious side effects and little follow-up by doctors. Some studies exclude children who have tried suicide and/or have symptoms of bipolar disorder (manic-depression). That could lower the odds of suicides occurring during the study. Children who already tried suicide are most likely to try again. In children with bipolar disorder, some antidepressants can unleash an attack of mania that leads to suicide.

Q: Why would children in studies become more suicidal on antidepressants than on sugar pills?

A: Researchers suggest two possible reasons:

• Antidepressants can trigger "akathisia," a sudden impulsiveness and frenzy that could cause already depressed children to attempt suicide.

• As the medicine begins to work, children who have been sad and withdrawn might gain just enough energy to act on suicidal feelings.

Q: Prozac is the only antidepressant approved for childhood depression, so why do doctors give kids other medicines such as Zoloft and Celexa?

A: Because these other antidepressants have been proven safe and effective in adults, doctors can legally prescribe them for children on an "off-label" basis, which means for conditions beyond the originally approved use. About two-thirds of the medicines used by children have never been tested on them, so such "off-label" use is common. Many doctors want options because they say some children respond well to one antidepressant but not to others.

Q: But does it make sense scientifically to think that children and teenagers will respond to antidepressants in the same way as adult patients?

A: So far they haven't responded in the same way. Only Prozac has proven effective for kids. An older class of antidepressants, called tricyclics, worked in adults and not children. The brains of children and teens are quite different from adult brains, research suggests. Also, a child's depression typically differs from an adult's depression. Kids move in and out of depressions more rapidly, and they're more influenced by the environment, particularly home and school, says child psychiatrist Harold Koplewicz, director of the New York University Child Study Center.

Q: Is there enough research to say that no antidepressant on the market but Prozac will ever be proven to work for childhood depression?

A: Scientists disagree on that. Thousands of children have participated in studies, and some experts call the evidence conclusive. But there's far more research on adults than children and teens. More than 10 times as many adults as children have been in antidepressant studies, estimates University of Texas child psychiatrist Graham Emslie, who did the first research showing Prozac's effectiveness in children.

Q: Is therapy as effective as drugs?

A: For children with mild depression, it's best to start with cognitive behavioral therapy (CBT), says Duke University child psychiatrist John March. The therapy teaches children how to overcome negative, pessimistic attitudes and tackle life problems. In March's new study, therapy alone didn't help, but children who received therapy plus Prozac were most likely to improve. "These kids were a lot sicker than those often in studies, and I think CBT could help many others who are depressed," March says. Even if a child takes antidepressants, he still should be in therapy and checked every week for side effects.

Q: Can childhood depression always be cured?

A: No. Even on the best treatment in March's study — CBT and Prozac — 30% of depressed children did not improve. Mental health experts say more research and better treatments are needed.

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