2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC42
  



  

  
Submitter : 
  

  
Dr. Paulo Negro
  

  
Date & Time: 
  

  
12/01/2006 09:12:53
  



  

  
Organization : 
  

  
Dr. Paulo Negro
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir/Madam,   



I am a psychiatrist with over 15 years of experience, including in the treatment of patients with severe mood disorders.  There is no reason to add a black box warning for adults receiving antidepressant agents.  Antidepresants agents are safe, effective, and at time life saving.  Treatment requires careful diagnostic examinations and follow up.  Please, do not add a further barrier to care by placing a black box warning, the outcome will be an increase of completed suicides.  It would be extremely helpful, however, that the FDA states against artificial barriers to assessment and follow up imposed by managed care.  Managed care imposes as a 'med check' consult a 15 minute time frame.  In order to improve patient safety, there should be no artificial barriers and no financial incentives to minimize the duration of follow up consultations to less than 25-30 minutes.  Same principles should apply to initial assessments, which require careful examination to rule out bipolarity, assess personality and perform a proper risk assessment of suicide risk. The FDA will protect patients by supporting the time structure of a good psychiatric practice.  The issue is not pharmacological, but time related. Thank you.