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In 2004, the Food and Drug Administration (FDA) issued a black-box warning on antidepressants indicating that they were associated with an increased risk of suicidal thinking, feeling, and behavior in young people. The agency's decision was immediately controversial: many members of the medical community worried that this warning would do more harm than good because it would discourage depressed patients from seeking help and discourage doctors from prescribing antidepressants when they were clinically indicated. Now, 10 years later, there are substantial epidemiologic data to address these important concerns. What effect has the FDA warning had on the rates of detection and treatment of depression? And is there any evidence that rates of suicide or suicide attempts have changed?

In retrospect, it seems that the FDA had little choice but to issue its black-box warning. The agency had conducted a series of meta-analyses of 372 randomized clinical trials of antidepressants involving nearly 100,000 participants, which showed that the rate of suicidal thinking or suicidal behavior was 4% among patients assigned to receive an antidepressant, as compared with 2% among those assigned to receive placebo,1 although none of the suicide attempts documented in the trials were fatal. Subsequent age-stratified analyses showed that this increased risk was significant only among children and adolescents under the age of 18 years; there was no evidence of increased risk among adults older than 24 years, and among adults 65 years of age or older, antidepressants had a clear protective effect against the development of suicidal ideation and behavior.


The meta-analyses provoked considerable debate about various methodologic issues. In particular, some experts questioned the validity of the assessment of suicidality in the trials that were included, which were generally not designed to prospectively assess suicidality.


The FDA was obviously mindful of the need to balance the small risk associated with antidepressant treatment against its proven benefits: an expanded black-box warning issued in 2007 stated that depression itself was associated with an increased risk of suicide. Has this well-intended warning accomplished its task — to educate clinicians about risk without discouraging appropriate treatment of depression?


Some worrisome trends in the rates of treatment of depression, diagnoses of new cases of depression, and suicide attempts since the black-box warning was issued suggest that the answer may be no. In a very large cohort study — including 1.1 million adolescents, 1.4 million young adults, and 5 million older adults — researchers examined automated health care claims data (for 2000 to 2010) derived from 11 health plans in the U.S. Mental Health Research Network.2 The study revealed significant reductions in antidepressant use within 2 years after the FDA advisory was issued: relative reductions of 31.0%, 24.3%, and 14.5% among adolescents, young adults, and adults, respectively. Although the downward trend in antidepressant use among adolescents reversed somewhat after 2008, utilization stayed below 2004 rates. In all age groups, rates of antidepressant use since the FDA warning was issued appear to have remained below the levels that would have been expected on the basis of pre-warning patterns.

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