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Antidepressants, Kids: Measuring Risks

March 6, 2006 — Antidepressant use appears to be associated with a modest increase in suicidal thoughts and behaviors among children and teens, but the drugs may or may not increase actual suicide risk.

Researchers with the FDA analyzed 24 clinical trials involving 4,582 pediatric patients taking one of nine antidepressant medications for depression, anxiety, or other psychiatric disorders.

None of the children or teens who participated in the studies actually committed suicide. But FDA investigators concluded that the patients taking active antidepressants were roughly twice as likely as patients taking inactive placebo pills to experience suicidal thoughts or attempt suicide.

FDA Action

The analysis was first reported to an FDA advisory panel in September 2004, leading the panel to order drug companies to change the labeling of antidepressants to warn that they might increase the risk for suicidal thinking and behaviors in children and teens.

The move led to a drop in antidepressant use in younger patients, as measured by the number of prescriptions filled.

But the FDA never meant to suggest that the drugs should not be used in this population, says study co-author Thomas Laughren, MD. Instead, he says, the warning emphasizes the need for close monitoring of young patients taking antidepressants for signs of suicidal behavior.

“What we are saying is that clinicians who prescribe them to treat children and adolescents need to see these patients frequently enough to look for signs of [suicidal thoughts and behaviors],” Laughren tells WebMD.

The analysis included too few patients to determine if antidepressant use increases suicide risk, he says, adding that the importance of the observed increase in risk of suicidal thoughts and behaviors remains unclear.

“The concern, of course, is that these [thoughts and behaviors] might predict an increase in suicides, but we can’t interpret this from these data,” he says.

Close Monitoring Critical

The FDA report notes that the actual rate of suicides among adolescents in the U.S. has been declining in recent years; at the same time the use of antidepressants among young people increased.

The analysis is published in the March issue of the American Medical Association journal Archives of General Psychiatry. In an accompanying editorial, Ross J. Baldessarini, MD, of McLean Hospital and Harvard Medical School, writes that the relevance of measuring suicidal thoughts and behaviors is not known.

“Suicidal [thoughts], as ascertained incidentally in trials, is a convenient but probably unreliable, nonequivalent and potentially misleading surrogate for suicidal attempts or suicides,” he writes.

He further notes that only a small fraction of patients with suicidal thoughts actually attempt suicide, few attempts end up in death, and individual patient characteristics also come into play.

Adolescent females are more likely to attempt suicide than older males, for example, but older males are more likely to actually succeed when they attempt suicide.

In an interview with WebMD, Baldessarini agrees that close monitoring of adolescent patients taking antidepressants is critical, especially early in treatment.

“We need to rethink the style of practice that we have been lulled into,” he says. “We need to take the time to get to know patients, instead of just prescribing these medications and sending them on their way. Nobody wants to pay for that, but that is what is needed.”

Posted by: Dr.Health

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