The Food and Drug Administration (FDA) has directed
manufacturers of all antidepressant drugs to revise
the labeling for their products to include a boxed
warning and expanded warning statements that alert
health care providers to an increased risk of
suicidality (suicidal thinking and behavior) in
children and adolescents being treated with these
agents, and to include additional information about
the results of pediatric studies. FDA also informed
these manufacturers that it has determined that a
Patient Medication Guide (MedGuide), which will be
given to patients receiving the drugs to advise them
of the risk and precautions that can be taken, is
appropriate for these drug products. These labeling
changes are consistent with the recommendations made
to the Agency at a joint meeting of the
Psychopharmacologic Drugs Advisory Committee and the
Pediatric Drugs Advisory Committee on September 13-14,
2004.

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