2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC26
  



  

  
Submitter : 
  

  
Dr. Paula Clayton
  

  
Date & Time: 
  

  
12/01/2006 09:12:42
  



  

  
Organization : 
  

  
American Foundation for Suicide Prevention
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 As physicians, we are taught to always consider the risk/benefit ratio of any treatment and here the risk is very low.  However, a black box warning may decrease the use of antidepressants, thus creating a dire risk/benefit ratio.  This has already occurred children and adolescents.  Depression is a real illness, with serious consequences that are debilitating. For 12 percent major depression is lethal.  



I have both prescribed and studied the use of antidepressants since 1958 and it would be impossible to count the number of people whose lives I have given back or saved with these medications.  Most of the data does not support that these drugs cause increases in suicidal thoughts or actions nor does any data show statistically significant differences in suicide in adult patients.  In fact, a recent analysis of more than 4,400 Medicaid records of patients who were hospitalized for depression by Dr. Mark Olfson, funded by our Foundation, found that adults who were treated with antidepressant drugs were no more likely to make a subsequent suicide attempt or die by suicide than those who were not treated with antidepressants (Olfson, Marcus & Shaffer, 2006).  



I understand the FDAs need to err on the side of caution and safety, but a black box warning would neither be cautious or safe, but put more lives in jeopardy.