Dataset Information

Long-Run Trends in Antidepressant Use Among Youths After the FDA Black Box Warning.

ABSTRACT: OBJECTIVE:In October 2004, the Food and Drug Administration directed pharmaceutical companies to issue a black box warning about the potential link between the use of antidepressants and suicidal ideation among children. This study analyzed long-run trends in antidepressant use among children before and after the black box warning for those with and without severe psychological impairment. METHODS:The analysis used data from the Medical Expenditure Panel Survey for children ages five to 17, covering years 2000-2011 (N=75,819). The study used multivariate probit models to compare the changes in the rate of any antidepressant use in the early (2004-2007) and late (2008-2011) postwarning years with the rate in the prewarning years (2002-2003). Recycled predictions methods were used to estimate yearly predicted probabilities of use. RESULTS:After adjustment for all covariates, there was a .5% statistically significant decline in the probability of using any antidepressants during the early postwarning years (2004-2007) compared with prewarning years. In the long run (2008-2011), however, there was no statistically significant difference. Five years after the black box warning, the adjusted rates of use increased to their prewarning levels (2.29% in 2003 and 2.26% in 2009). The initial impact of the warning differed between the severe and nonsevere populations, with a significant effect on those with nonsevere psychological impairment. CONCLUSIONS:The return to the rates before the black box warning raises concern that the impact of the warning may have dissipated over time. More frequent updates of the warning might be necessary.

SUBMITTER: Kafali N

PROVIDER: S-EPMC5942898 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Long-Run Trends in Antidepressant Use Among Youths After the FDA Black Box Warning.

Kafali Nilay N Progovac Ana A Hou Sherry Shu-Yeu SS Cook Benjamin Lê BL

Psychiatric services (Washington, D.C.) 20171215 4

<h4>Objective</h4>In October 2004, the Food and Drug Administration directed pharmaceutical companies to issue a black box warning about the potential link between the use of antidepressants and suicidal ideation among children. This study analyzed long-run trends in antidepressant use among children before and after the black box warning for those with and without severe psychological impairment.<h4>Methods</h4>The analysis used data from the Medical Expenditure Panel Survey for children ages f ...[more]

PMID: 29241433

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Project description:The United States Food and Drug Administration issued a Black Box warning in October 2004 after placebo-controlled trials of antidepressant medications found an increased risk of suicidal thoughts and behaviors among children and adolescents taking antidepressant medications relative to placebo. Subsequently, some researchers have concluded that the Black Box warning caused severe unintended consequences; specifically, they have argued that the warning led to reduced use of antidepressants among youth, which led to more suicides. In this paper, we critically examine research regarding the Black Box warning's alleged deleterious consequences. One study claimed that controlled trials did not actually find an increased risk of suicidality among youth taking fluoxetine relative to those taking placebo, but its measure of suicidality is likely invalid. We found that ecological time series studies claiming that decreasing antidepressant prescriptions are linked to higher rates of suicide attempts or actual suicides among youth were methodologically weak. These studies exhibited shortcomings including: selective use of time points, use of only a short-term time series, lack of performing statistical analysis, not examining level of severity/impairment among participants, inability to control confounding variables, and/or use of questionable measures of suicide attempts. Further, while some time-series studies claim that increased antidepressant prescriptions are related to fewer youth suicides, more recent data suggests that increasing antidepressant prescriptions are related to more youth suicide attempts and more completed suicides among American children and adolescents. We also note that case-control studies show increased risk of suicide attempts and suicide among youth taking antidepressants, even after controlling for some relevant confounds. As clinical trials have the greatest ability to control relevant confounds, it is important to remember such trials demonstrated increased risk of suicidality adverse events among youth taking antidepressants. The Black Box warning is firmly rooted in solid data whereas attempts to claim the warning has caused harm are based on quite weak evidence.

Dataset Information

Long-Run Trends in Antidepressant Use Among Youths After the FDA Black Box Warning.

Publications

Long-Run Trends in Antidepressant Use Among Youths After the FDA Black Box Warning.

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