Caution Urged on Antidepressants and Children

The U.S. Food and Drug Administration announced on Friday that it had revisited data regarding antidepressants and suicidal thinking and behavior in children, and said the data may have enough merit to warrant new labels. Specifically, an analysis by senior FDA epidemiologist Dr. Andrew Mosholder found that, overall, children using antidepressants were 1.8 times as likely to have suicidal tendencies as depressed children taking placebos.

This is just the latest chapter in a controversy dating back to last year, when British health officials declared that all antidepressants except Prozac should not be used in children and adolescents.

Regardless, earlier this year two expert advisory committees to the FDA recommended that labeling be changed to reflect the need to monitor all patients more closely. The agency then asked manufacturers to change the labels of 10 drugs.