FDA Orders Warning on Kids' Antidepressant Use

FDA Orders Warning on Kids' Antidepressant Use
October 18, 2004

News Summary

The Food and Drug Administration (FDA) has issued an order requiring all antidepressant drugs to carry a warning that is prominently displayed in a black box on the label, the Washington Post reported Oct. 16.

The warning is aimed at doctors. "The use of these products causes a statistically significant increase in suicidal thoughts and behavior among children," said Lester Crawford, acting director of the FDA.

In clinical trials, children who were given antidepressants had a 4-percent risk of having suicidal thoughts and behavior, compared with a 2-percent risk among children who received placebos during the study.

The FDA first learned about problems among children taking the drugs from British authorities; congressional investigators are looking into why the FDA waited so long to issue warnings.

The FDA contends that trials conducted in recent years failed to clearly distinguish suicidal thoughts and behavior from other side-effects.

The American Psychiatric Association said it had "deep concern" over the black-box warning and the "chilling effect" it could have on treatment.

"We believe the biggest threat to a depressed child's well-being is to receive no care at all," said a statement from the association.