Labeling for antidepressants

FDA is reviewing the use of antidepressants by children and its relationship to suicidal thoughts and actions.

It asked Columbia University to examine reports of studies done on the effects of some antidepressants used by children. The agency will solicit public comment and ask for advice from its own advisory committees for labeling changes that may be needed for these drugs.

Earlier in 2004, the advisory committees said the labeling should call attention to the need to monitor patients more closely when initiating drug therapy. FDA asked manufacturers of 10 antidepressants to change their labels. Seven of the 10 now bear stronger warnings, and manufacturers of the remaining three say they will change their labels as well. Additional steps may be taken in the wake of the Columbia University study.

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