FDA Announcement on Black Box Warning Label for Antidepressants Used With Children

Posted on October 15, 2004

Providing both doctors and parents with complete information represents sound clinical practice. Discussion of benefits and risks in prescribing any medication or course of treatment is essential.

Close monitoring is appropriate. So too is the need for a clear warning that depression and other psychiatric disorders can have significant consequences, including suicidality, if not appropriately treated.

The FDA’s press release claims that the "new warning language recognizes this need" while advising close monitoring as a way to manage the risk. However, the FDA’s recognition of the risk is NOT included in the actual black box warning language nor clearly stated in other labeling changes. This is a serious omission. Untreated mental illness poses a very real risk of suicide. We know that 80 percent of children today with mental health problem are not getting any treatment. Suicide in fact is the third leading cause of death among young people ages 15 to 24, constituting an even broader public health crisis.

The new labeling also does not recognize that antidepressants combined with psychotherapy represent the most effective course of treatment.

The risk now is that the FDA’s incomplete warning language may simply discourage pediatricians from prescribing antidepressants at all—at a time when there is a severe shortage of child psychiatrists nationwide.

Greater education and training of doctors will be needed, besides greater education and dialogue with parents. Otherwise, the risk of unintended consequences may end up greater than the risks behind the FDA’s action.