2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC38
  



  

  
Submitter : 
  

  
Mr. Wylie Tene
  

  
Date & Time: 
  

  
12/01/2006 09:12:06
  



  

  
Organization : 
  

  
American Foundation for Suicide Prevention
  



  

  
Category : 
  

  
Other Organization
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 It is important to learn lessons from the previous warning on antidepressants, which has resulted in a significant drop in prescription rates due to inaccurate media coverage and change in public perception.  There is now preliminary research showing an increase in suicides among children and adolescents due to the lowered prescription rates.  



Another Black Box Warning could contribute to more misconceptions and groundless fears about antidepressant use in adults.  The real fear is that the medias portrayal and public reception of a black box warning could lead to a decrease in the treatment of depression, a real illness, and ultimately increase the rates of suicide among adults  the one thing the FDA is trying to prevent.  



As a media expert for the past decade, I understand the powerful role the media can play in public reception.  If the FDA determines another black box warning is necessary, and I dont believe the evidence will support that, the FDA must do a better job of explaining to the media and public the real risks of not treating depression.  Failure to do so could be detrimental to public health.