The FDA directed manufacturers of all antidepressant drugs to revise
the labeling for their products to include a boxed warning and extensive
warning statements that alert health care providers to an increased
risk of suicidality in children and adolescents being treated with these
agents, and to include additional information about the results of
pediatric studies.
The FDA also informed these manufacturers that it has
determined that a Patient Medication Guide (MedGuide)-which will be
distributed 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.
In addition to the boxed warning and other information in professional
labeling on antidepressants, MedGuides are being prepared for all of
the antidepressants to provide information about the risk of suicidality
in children and adolescents directly to patients and their families and
caregivers. The pharmacist, with each new prescription or refill of a
medication, should distribute MedGuides.
Based on the conclusive data from the 24 trials conducted, the FDA has
determined that the following points are appropriate for inclusion in
the boxed warning:
1. Antidepressants increase the risk of suicidal thinking and behavior
(suicidality) in children and adolescents with MDD and other
psychiatric disorders.
2. Anyone considering the use of an antidepressant in a child or
adolescent for any clinical use must balance the risk of increased
suicidality with the clinical need.
3. Patients who are started on therapy should be observed closely for
clinical worsening, suicidality, or unusual changes in behavior.
4. Families and caregivers should be advised to closely observe the
patient and to communicate with the prescriber.
5. A statement regarding whether the particular drug is approved for
any pediatric indication(s) and, if so, which one(s).