2004N-0330 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee
FDA Comment Number : EC50
Submitter : Dr. Marc Schwartz Date & Time: 10/07/2004 04:10:20
Organization : Yale University
Health Professional
Category :
Issue Areas/Comments
My name is Marc Schwartz. I am a senior psychiatry resident at Yale, chief
of the consultation-Liaison service at Yale New Haven Hospital. I'm
currently applying for a Child & Adolescent Fellowships at this time. I'm
writing you out of concern about the SSRI's issue in children. As we know,
SSRI's have been proven safe, well tolerated, and important medications in
the treatment of depression. The recent press about the link between
suicide and SSRI's by the media has been damaging. I would hope that the
FDA would keep in mind that many things contribute to suicide in children
and adolescents. A "Black Box" warning would be detrimental to the
treatment of depression in this population, especially from a media
standpoint. If this is to be inevitably the case however, perhaps a new
precedence could be set. That is, a "Black Box" for all physicians except
Child and Adolescent Psychiatrists who are trained specifically for this
population and who understand how to recognize and treat signs of
suicidality. This novel idea would leave open to the media and public that
under the proper supervision and treatment, SSRI's are powerfully effective
in the treatment of depression. Without this exception, I'm afraid that
parents would be missing an important tool that we have in our arsenal in
the modern treatment of depression. Change is good. Creating a new
category by the FDA can be good too.

Thank you,