Experts urge caution in using SSRIs for depressed kids
■ The FDA orders a review of conflicting data on the role these antidepressants play in suicidal thinking by children and teens.
By Susan J. Landers — Posted March 1, 2004
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Washington -- The Food and Drug Administration is expected to decide by summer whether antidepressants should be prescribed for children. In the meantime, physicians and parents are cautioned that the medications, while helpful, could lead some children to consider suicide.
The federal agency asked researchers at Columbia University to review the available data on the use of selective serotonin reuptake inhibitors in children and teens. The FDA hopes this review will produce a more definitive answer about whether these medications are more likely to help or hurt.
Two FDA advisory panels reviewed existing data in early February and heard often emotional testimony from parents. The data and the testimony provided a conflicting picture -- some studies claiming the SSRIs led to an increase in suicidal thoughts while others found no evidence of harm. Meanwhile, some parents presented heart-rending stories of their children's suicides while others said the drugs saved their children's lives.
The conflicting data and testimony indicate there is no simple answer to the question, said David Fassler, MD, who testified before the panels for the American Psychiatric Assn. Dr. Fassler is a clinical associate professor of psychiatry at the University of Vermont.
"In some of the studies it seems that there could be a slight increase in the risk of suicidal thinking, but other studies seemed to show the exact opposite," said Dr. Fassler. "It also was apparent that the studies used different definitions of suicidal thinking and behavior."
Presentations revealed that depression affects a significant number of children and adolescents, between 3% and 5%, and as many as one-third of these children will attempt suicide at some point during the course of their illnesses.
"So it became clear that the most dangerous course of action is not to treat kids at all," said Dr. Fassler.
Although the medication is often helpful in treating depressed children and teens, it should only be used as a component of a comprehensive treatment plan developed after a thorough evaluation that includes interviews with family members and school personnel, said Dr. Fassler.
The American Academy of Child and Adolescent Psychiatry testified that SSRIs can be effective in treating children and adolescents and expressed support for a report released in January by the American College of Neuropsychopharmacology that the benefits of the antidepressants for children outweigh their risks.
The AACAP also urged the FDA to provide broader dissemination of information gained from pediatric clinical trials and asked the agency to require the registration of all clinical trials.
This new dialogue is occurring after a series of divergent decisions were made over the use of SSRIs for children and teens. Great Britain warned its physicians against prescribing any SSRI antidepressant drug except fluoxetine (Prozac) for depressed youth younger than 18, while the FDA warned against the use of one SSRI, paroxetine (Paxil), but stopped short of warning against the use of other SSRIs.
The FDA has approved Prozac for treating children with depression, and its review of three trials determined that Paxil was no more effective than placebo in treating depressed children and teens. The FDA expanded its advisory last fall and urged physicians to closely monitor children and adolescents on SSRIs for changes in their clinical state and for increased suicide risk.
Dr. Fassler worries that the conflicting messages and emotional testimony will unintentionally frighten parents and make them reluctant to seek help for their children. "That would be a tragedy."
"The good news is that we really can help most of these kids. The real tragedy is there are so many kids who aren't getting the effective treatment they need," he added.
The APA called for more large-scale, multisite clinical studies to determine dosages, response rates and side effects. "Children are not just little adults when it comes to medication," said Dr. Fassler.