10 Years Later: The Effects of Antidepressant Black Box Warnings

the MPR take:

Ten years ago, the Food and Drug Administration (FDA) issued a requirement that antidepressant packaging include a “black box” warning with information on the increased risk of suicidal ideation and behaviors in children and young adults taking these medications. The FDA was prompted to review the risk after paroxetine was associated with an increase in suicidal ideation, although there were no suicides among children in clinical trials of the drug. An analysis of existing data on patients taking antidepressants showed a slight increase in suicidal ideation and behaviors (4% for those taking antidepressants vs. 2% on placebo). Many experts today believe that the warning has accomplished more harm than good by discouraging patients from seeking appropriate treatment with antidepressants; a BMJ study this year found a link between greater awareness of the warning to a drop in use of antidepressants, along with an increase in suicide attempts among young people. The FDA’s decision was intended to ensure that clinicians and patients would discuss risks associated with the drugs, particularly in the early months of treatment when symptoms may worsen before they improve; the agency has no current plans to revisit the warning mandate.

The so-called “black box” is the most severe warning label issued by the Food and Drug Administration (FDA), and for the past decade, antidepressants have been among the drugs that bear them. But now, many experts say it's time for the black box to go: that the warnings overstate the real risk and may deter doctors from prescribing them to people who could benefit from being on antidepressants.

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