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 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 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,

Marc