2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC37
  



  

  
Submitter : 
  

  
Dr. Mark Komrad
  

  
Date & Time: 
  

  
12/01/2006 09:12:55
  



  

  
Organization : 
  

  
Mark S. Komrad M.D.
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 November 30, 2002

To:  The FDA





I understand that the FDA is considering instituting  a black box warning about SSRI antidepressants regarding safety problems, in the absence of firm scientific evidence of significant safety problems that would merit such a dire action.  



As a practicing psychiatrist of 20 years I want the FDA to understand that I have NEVER seen significantly dangerous side effects from SSRIs despite using them hundreds of times since they have come out.  The scientific data supports my clinical experience. In fact, what made them revolutionary was their IMPROVED safety over the older tricyclic and MAO inhibitors.  Their safety and efficacy has lead to a revolution in acceptability among patients, tolerability, and their accessibility--especially in primary care where the majority of prescriptions are written.  



Their safety has allowed primary care physicians in particular to feel comfortable about providing SSRI prescriptions to depressed people without worry about safety issues.  Studies do confirm that this safety aspect has lead to markedly increased treatment of depression in primary care settings using SSRIs, since that category of medication was invented. These are profoundly lifesaving medications.  



A black box warning would be, sociologically, a significant psychological barrier to care in a field where there are already profound psychological and economic barriers that  interfere with access to treatment and hence have a major impact on  public health.  A black box warning  needs to be issued only with the greatest of discernment and care -- based on the strongest, most compelling evidence of safety issues.  The current clinical and scientific experience with SSRIs simply does not merit such a warning for this category of medicine. 



What would be helpful is if the FDA encouraged careful monitoring of patients on these medications, especially when starting, stopping or changing doses.  I continue to support the FDA making science-based decisions in the best interest of patients.  That approach, I believe should lead it AWAY from a black box warning on SSRIs at this juncture.



Sincerely,



Mark S. Komrad M.D.

Psychiatrist, Private Practice

Board Member, Maryland Foundation for Psychiatry

Chair of Clinical Ethics, Sheppard Pratt Health Systems, Baltimore, MD