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FDA Advisory Committee Recommends "Black Box Warnings" for Anti-depression Medications

September 15, 2004

A Food and Drug Administration (FDA) advisory committee held two days of meetings on September 13th and 14th to make recommendations on the use of anti-depression medications (5 selective serotonin reuptake inhibitors -- Celexa, Luvox, Paxil, Prozac, and Zoloft and 4 atypical anti-depressants – Wellbutrin, Remeron, Serzone, Effexor) for children and adolescents and the risk of suicide. Prozac is the only medication specifically approved by the FDA for children and adolescents. The FDA generally follows the recommendations of its advisory committees.

The meetings included a public hearing during which families, advocacy groups and others presented statements related to the use of anti-depressants to treat major depression and the risk of suicidality. Dr. Ken Duckworth, NAMI’s Medical Director, provided a statement to the committee on behalf of NAMI. The meetings also included presentations by experts in child psychiatry and pediatric suicidality related to the use of antidepressants and the risk of suicidality.

In its statement, NAMI called for increased research to better understand the effectiveness and safety of anti-depressant medications in children, close monitoring of youth prescribed these medications as part of sound clinical practice, better training for providers treating youth with major depression, transparency in the research data so that families and providers have access to the results of all clinical trials and better communication with families about the risks and benefits of the medications.

NAMI asked the committee not to recommend action that would restrict safe and effective treatment options at a time when youth suicide is a public health crisis – with more than 3,000 young lives lost every year.

Studies presented during the meetings showed that anti-depressant medications increased the risk of suicidal behavior and ideation in children and adolescents. Despite these findings, the overall risk of suicide remains quite low. There were no suicides in the 4,000 youth included in the clinical trials for anti-depressant medications that were presented to the committee. But the research also did not demonstrate the effectiveness of many of these medications in treating major depression in youth.

Several committee members expressed concern that there is not enough information to really know what to do – the current studies are too small, too short in duration and have not uniformly defined suicidal behavior to ensure reliable results. The committee called for more research to better understand the risks of suicidal behavior associated with prescribing anti-depressant medications for youth and recommended that the research be conducted by NIMH and not by the pharmaceutical industry.

In the end, the committee voted (15-8) to recommend that the FDA require a "black box" warning that cautions that children taking anti-depressant medications are at an increased risk of suicidal behavior and thinking. A "black box" warning is the strongest warning that can be provided and is printed in boldface type at the top of a medication’s label. The FDA advisory committee also recommended that the FDA require that pharmacists distribute patient information with warnings related to use of the medication.

In the wake of this decision, NAMI will develop and disseminate appropriate materials for families and providers that will enhance their understanding of the risks and benefits of treatment options for depression in children and adolescents.

To review a copy of NAMI’s statement that Dr. Duckworth presented to the FDA advisory committee, please click here