MONDAY, March 6, 2006 (HealthDay News) -- Antidepressants may be associated with a small increase in suicidal thoughts and behaviors in children, a new analysis of existing research indicates.
The study, which appears in the March issue of the Archives of General Psychiatry, extends a prolonged debate about the safety of antidepressant use in children and teens.
In October 2004, the U.S. Food and Drug Administration directed manufacturers of a newer class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) to revise their labeling to include a "black box" warning to alert health-care providers to an increased risk of suicidality in children and teens.
In July 2005, the FDA issued a public health advisory that raised the possibility that the risk of suicidality also applied to adults taking SSRIs, after several studies pointed to that possibility.
Meanwhile, British health authorities have declared that all antidepressants except Prozac should not be used by children or adolescents.
Prozac is the only medication approved to treat depression in children and teens. Other drugs are used, however, based on evidence of their effectiveness from clinical trials.
The new study generated no new data but, instead, reviewed information from 24 completed clinical trials on pediatric patients taking one of nine antidepressant medications. The studies involved 4,582 children and teens who had been diagnosed with juvenile major depression, obsessive-compulsive disorder, anxiety, social anxiety or attention-deficit disorder.
The meta-analysis was performed by staff at the FDA.
Only one trial, funded by the National Institute of Mental Health, found a significant increase in suicidality -- more than fourfold. When the data from all the studies were pooled, however, there was no statistically significant increase in risk.
Overall, children with depression taking SSRIs had a 66 percent higher risk of suicidal ideation and behavior. For all drugs taken by depressed youngsters, the increased risk was almost double.
But other experts warn that suicidality is not the best way to measure a drug's safety.
"While there is some evidence suggesting risk, the subjective nature of suicidality as an independent measure leaves much to be desired," said Dr. Jon A. Shaw, director of child and adolescent psychiatry at the University of Miami School of Medicine. "It is often difficult to elicit one's thoughts about suicide because there are so many mediators that determine if a child or adolescent will feel free to talk about suicide ideation."
"We know that approximately 20 percent of high school kids will endorse suicide ideation," he continued. "The failure to note differences in behavior, such as suicidal attempts or suicide, makes the data less than conclusive, given the evidence in other literature that antidepressants may decrease suicidal behavior. The important take-away message is to be judicious when using [antidepressants], and weigh the potential cost-benefit analysis."
More information
The National Institute of Mental Health has more on treating mental disorders in children.
