What is the black box warning on antidepressant medications

What is the black box warning on antidepressant medications prescribed to children? What does it warn of? What does research about this show?

Solution

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.

A black-box warning is the most serious type of warning in prescription drug labeling.

The warning also notes that children and adolescents taking SSRI medications should be closely monitored for any worsening in depression, emergence of suicidal thinking or behavior, or unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment. SSRI medications usually have few side effects in children and adolescents, but for unknown reasons, they may trigger agitation and abnormal behavior in certain individuals.

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.

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.

. 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.

Moreover, it is not only antidepressant prescribing rates that have fallen in the wake of the black-box warning, but also the rate of diagnosis of new cases of depression.Given that the agency\'s 2007 modification of the black-box warning has not been sufficient to prevent what seems to be a chilling effect on depression treatment perhaps the mere presence of a warning speaks louder than any clarification it may contain