2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC33
  



  

  
Submitter : 
  

  
Dr. Andrew Rudo
  

  
Date & Time: 
  

  
12/01/2006 09:12:50
  



  

  
Organization : 
  

  
Main Street Community Mental Health Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sirs,

As you know, depression is a tremendous health problem in our country as well as the rest of the world. Its most prominent deleterious effect is suicide. I have been a practicing psychiatrist in the Maryland area for over 26 years and have prescribed antidepressant medication for all of those years. The preponderance of the evidence in studies and in my clinical practice is that antidepressant medicines, particularly the newer generation of medicines that started with Prozac, are for the most part, lifesavers through their profound ability to improve mood, relieve depressive symptoms and avert suicidality. The side effect of increased suicidality is such a rare occurence that a black box warning would do more harm than good in my professional opinion. Patients are often very well informed in this Internet generation and would often tragically be put off to trying medication if such a black box warning were added or increased. More important to safety is physicians continuing to educate their patients on the small but important risk at times of initiation of medication and dosage increase, helping patients and their loved ones be educated responsible participants in keeping their treatment as effective and safe as possible.

Thank you for your consideration of my views.