Suicidality in Children and Adolescents

[Guest guest]

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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