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Suicidality in Adolescents and the Black Box Warning

Suicidality in Adolescents

Suicidal ideation and suicide attempts are common in adolescence and do not have the same prognostic significance for completed suicide as those behaviors in later life. Quoting data from the Youth Risk Behavior Study, the federal Centers for Disease Prevention and Control (CDC), reports that 17% of adolescents think about suicide in a given year1. Among high school students, 12% of girls and 5% of boys attempt suicide in a given year. Ultimately, 2 per 100,000 girls and 12 per 100,000 boys die as a result of such attempts — a ratio of attempts to completed suicides is 6,000 to 1 among girls and 400 to 1 among boys. In the U.S., this translates into approximately 2000 young people who die each year as a result of suicide. Fortunately, however, the overall rate of suicide in the 10-19 year age range has declined by 25% over the past decade. Since this decade has been associated with a dramatic
increase in the prescription rates of the newer SSRI antidepressants, a recent study has demonstrated that a 1% increase in prescription of antidepressant medication was associated with a 0.23 per 100,000 decrease in adolescent suicides.2  

The Black Box Warning

In 2004, the FDA reviewed detailed reports of 24 clinical trials involving more than 4,400 children and adolescents who had been prescribed any of nine antidepressants for treatment of major depression, anxiety, or obsessive-compulsive disorder3. No suicides occurred in any of these trials. The FDA concluded that more of the children and teens who were receiving an antidepressant medication spontaneously reported that they thought about suicide or made a suicide attempt than did those who received a placebo. The FDA’s analysis showed that about 2 out of 100 children not taking medication would spontaneously report suicidal thoughts and/or behaviors, compared to 4 out of 100 who were taking medication. These rates need to be understood in the context of findings from community samples cited previously in which as many as half or more of teenagers with major depression are thinking about suicide at the time of diagnosis and some 16% to 35% have made a previous suicide attempt. Although only nine medications were re-examined in the analysis, the FDA applied the labeling changes to all antidepressant medications. This was done on the basis of the advisory committee’s concern that applying the warning only to the newer antidepressants reviewed would give doctors and patients the false impression that older antidepressants such as TCAs had a more favorable risk-benefit ratio. Since the FDA warning, the rate of prescription of antidepressants in youth in both the US and Canada has decreased substantially. In parallel, there has been an increase in completed suicides in youth. Although a causal link cannot be established, many experts argue that this is evidence that antidepressants are effective in preventing suicide in youth.

 

1 Available at www.cdc.gov/HealthyYouth/YRBS/pdfs/trends-suicide.pdf. Accessed 12/29/2004 
2 Olfson M, Shaffer D, Marcus SC, Greenberg T. (2003). Relationship between antidepressant medication treatment and suicide
in adolescents. Arch Gen Psychiatry 60:978-982.
3 T.A. Hammad. Results of the Analysis of Suicidality in Pediatric Trials of Newer Antidepressants. Presentation at the FDA
Center for Drug Evaluation and Research (CDER), Bethesda, MD. September 13, 2004. Available at:
www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologidDrugs. Accessed January 5, 2005.

(Adapted from the APA / AACAP’s PhysiciansMedGuide) and excerpted from GLAD-PC toolkit gladpc.org.)