2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC27
  



  

  
Submitter : 
  

  
Dr. William Prescott
  

  
Date & Time: 
  

  
12/01/2006 09:12:56
  



  

  
Organization : 
  

  
Maryland Psychiatric Society
  



  

  
Category : 
  

  
Health Care Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am writing on behalf of the Maryland Psychiatric Society, a professional organization representing over 700 Maryland psychiatrists.  We wish to provide public comment for the FDA Psychopharmacologic Drugs Advisory Committee to review for the December 13 hearing on "2006N-0414 Suicidality data from Adult Antidepressant Trials."



An estimated 14 million Americans suffer from depression annually, with the average worker unable to work for 35 days per year.  It is well- established that major depression is associated with a lifetime mortality of 8-10% related to suicide.  There are some 30,000 annual U.S. suicides, 80-90% of them secondary to mood disorders.  Unfortunately, in 2002 only one-fifth of people with depression received adequate treatment. Successful treatment of depression reduces the risk of suicide, and reduces the morbidity and lost productivity related to depression.  Three-fourths of individuals treated for depression are treated by their primary care physician.  Primary care physicians are responsible for the majority of antidepressant prescriptions.  The risks of increased suicidal ideation and suicide attempts are inherent in the treatment of depression, with or without medication. 



It is clear that a black boxed warning about increased suicidality with antidepressants, whether clearly proven or not, will deter many prescribers (particularly non-specialists) from using this effective treatment modality.  This will result in an increased number of avoidable suicide attempts and completed suicides.



Any assessment of the risks and benefits of adding a black boxed warning should be balanced by an assessment of the estimated number of increased suicide attempts and completed suicides, and the increased amount of morbidity and lost productivity, related to prescriber avoidance of antidepressant medications due to medico-legal fears.  How many additional lives will be lost due to this regulatory decision?



Sincerely,

 

William G. Prescott, M.D.

President