Over the past year, developments in pharmaceutical research and public policy—both in the United States and abroad—have changed physicians' views about antidepressant use in children. Formerly mainstays in the treatment of children with depression, antidepressants have come under fire recently for not being as safe for children as was originally thought. Why the sudden change in thinking? How did a once widespread treatment begin to cause so much concern?

A Recent History

A fast-growing phenomenon in the United States, the use of antidepressants in children had almost tripled over the past few years and was quickly approaching the prescription rate for adults. In 2002, more than 10 million antidepressant prescriptions were written for between one and two million children in America.

Additionally, an Express Scripts Inc. study of two million children released in April 2004 found that the fastest growing group of children being prescribed antidepressants is children under the age of five, with use among girls doubling and use among boys increasing by 64 percent. Despite the fact that the only antidepressant with Food and Drug Administration (FDA) approval for use in children with depression is Prozac, children were prescribed a wide range of the common antidepressants in an "off-label" use. The most commonly prescribed antidepressant for young people is Zoloft; Prozac ranks second.

Antidepression Medication-Suicide Link?

In June 2003 researchers in the U.K. announced their discovery that children taking the selective serotonin reuptake inhibitor (SSRI) paroxetine—also known as Paxil—had an increased risk of suicide. Doctors in the U.K. were cautioned against prescribing Paxil, as well as six other antidepressant medications, to patients under the age of 18. In the U.S., the FDA began its own investigation—an investigation similar to one it conducted in the 1980s when suicide concerns arose in connection with adult use of Prozac. In that case, after widespread publicity and numerous studies, the Prozac-suicide link was dismissed as unfounded. The link between Paxil and suicide in children, however, has held up under scrutiny thus far.

In the wake of months of investigation, the FDA released a report in September of 2004 acknowledging the increased risk of suicide in children who take antidepressant medication. Studies suggest that children on antidepressants have twice the risk of suicidal behaviors as those on sugar pills. An estimated two to three percent of children taking antidepressants will have suicidal thoughts or behaviors, now believed to be caused by the medication.

Doctors Strongly Cautioned

In the statement it issued in September, the FDA warned physicians to exercise caution in prescribing antidepressants to children and urged manufacturers to include "black box" warnings on all antidepressants. Black box warnings are strong cautions that accompany certain medications, alerting physicians to the possibility of any serious risks known to be associated with the drugs. In this case, the black box warning advises doctors to monitor their young patients closely for signs of worsening depression, suicidal thoughts, or suicidal behaviors.

All antidepressants currently prescribed for children, including Zoloft, Effexor, Celexa, Wellbutrin, Remeron, Serzone and Luvox* will bear the warnings. While making safety a priority is responsible, child mental health advocates worry that the black box warnings have the potential to do more harm than good for some young patients: If the warnings stop physicians from prescribing these drugs even when they are truly needed, some children may be left untreated and therefore at risk for suicide anyway—due to their depression.

*Brand names of medications are the registered trademarks of the manufacturers.