NAMI Urges the FDA to Promptly Issue Guidance on the Use of SSRIs to Treat Major Depression in Children

Posted on February 2, 2004

Arlington, VA — NAMI calls on the U.S. Food and Drug Administration (FDA) to provide clear guidance to families and mental health providers on the safe and effective treatment of major depression in children--after reviewing all of the relevant research data.

"As a psychiatrist who treats children with major depression, and mother of two children who suffer from depressive illness, there is a critical need to ensure that families nationwide understand the best way to help their children deal with the sometimes life-threatening illness of depression," stated Dr. Suzanne Vogel-Scibilia, a NAMI national board member. "We know from personal experience that selective seratonin reuptake inhibitors (SSRIs) have saved the lives of many children, and parents need the benefit of this FDA data review."

Following two conflicting reports on the benefits and risks of prescribing certain antidepressants for children and adolescents with depression, the FDA today convened a meeting to consider current research data and the need for further research in this area.

Britain’s Medicines and Healthcare Products Regulatory Agency and the FDA issued warnings last year that stated that increased suicidal ideation and suicide attempts in clinical trials were associated with the use of Paxil—a SSRI used to treat adolescents with major depression.

However, the link between SSRI use in adolescents with depression and suicide is weak, according to a preliminary report released by the American College of Neuropsychopharmacology (ACNP)—whose special task force of nationally recognized psychiatrists evaluated evidence from clinical trials and studies. This analysis led the task force to conclude that SSRI use did not cause increased suicide attempts or ideation in youth being treated for depression. On the contrary, the data reviewed by the ACNP task force demonstrated efficacy in the use of SSRIs to treat youth with major depression.

"Psychotropic medications for children with mental illnesses should be used only when the anticipated benefits outweigh the risks," stated Dr. Suzanne Vogel-Scibilia. "Research shows that early identification and comprehensive treatment can improve the long-term prognosis of children with mental illness. Research on the effectiveness of treatments is our best hope for the future."

"NAMI is concerned that any limitations on the ability of knowledgeable practitioners to treat children with SSRIs, when needed, could be damaging to children in our country—especially those with serious, life-altering illnesses," according to Dr.Vogel-Scibilia, who appeared today before the FDA committee on behalf of NAMI.

"There is some epidemiological evidence that the overall use of SSRIs has had a positive effect in reducing suicides in adolescents," said Dr. Ken Duckworth, NAMI medical director and a child and adolescent psychiatrist. "However, the field clearly needs more and better research to understand the effects of SSRIs in treating depression in children."

The discussion of pediatric medicine and SSRI use in children and adolescents must also address the critical need to ensure that all children and adolescents with mental illnesses have access to evidence-based assessments, interventions and quality clinical care. According to Dr. Vogel-Scibilia, "the lack of effective and appropriate treatment for children with mental illnesses will adversely affect a child’s overall development including the child’s ability to learn, develop self-esteem, socialize and function in the community." We simply must ensure that children with mental illnesses have access to safe and effective treatments to avoid the continued suffering and unnecessary tragedies that occur nearly every day in this country.

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As The Nation’s Voice on Mental Illness, NAMI leads a national grassroots effort to transform America’s mental health care system, combat stigma, support research, and attain adequate health insurance, housing, rehabilitation, jobs and family support for millions of Americans living with mental illnesses. NAMI’s one thousand affiliates are dedicated to public education, advocacy and support and receive generous donations from tens of thousands of individuals as well as grants from government, foundations and corporations. NAMI’s greatest asset, however, is its volunteers--who donate an estimated $135 million worth of their time each year.

Related Links

Dr. Vogel-Scibilias Full Statement
Information on todays FDA briefing (from FDA.gov)
Coverage of the briefing from CNN.com
NAMIs Child and Adolescent Action Center