2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC28
  



  

  
Submitter : 
  

  
Mr. Eric Swan
  

  
Date & Time: 
  

  
12/01/2006 09:12:06
  



  

  
Organization : 
  

  
Mr. Eric Swan
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Its about families like yours.





My name is Eric Swan and I am writing today because of the death of my brother-in law, Tim Witczak, known to most as Woody.



I would have preferred to present this to you in person and am disappointed that the lottery system has forced this to be electronic.   That said, please consider the following.



Three years ago my Woody went to his family physician having trouble sleeping.  After a short consultation he walked out with samples of Zoloft.   Woody was not depressed or had any history of depression.  He had just started his dream job with a new company as national sales manager. He was excited about the opportunity but sleep was an issue as with most people starting companies.   Shortly after the starting the drug the side effects began.   Along with diarrhea and sweating, Woody experienced a strange sensation of feeling outside of his body.   He also became very agitated and not himself.  The drug changed Woody.  Five weeks after his initial appointment and starting Zoloft, we found Woody dead at age 37.  He hung himself in his garage.   His story is told in greater detail at www.woodymatters.com



We wish Woody would have had the same warning the FDA placed on Zoloft for Kids in 2004.   That is what we are talking about in this hearing.   The central question is do we warn adults the same as we now do for human beings 18 and under?   Without a doubt the answer should be yes.


There are many other issues that seem to arise around these hearings.  Please stick to the central question at hand.   We do not ask that these drugs be taken away or any doctor or patient not have ssris as a treatment option.  Depression is serious and needs to be treated with many options and from many available angles.   This in no way however excuses not warning ALL Americans of a risk already established in people by the 2004 black-box warning.



Stop the confusion and warn all patients of this risk.  I tell you from experience; if it can happen to our family member it can happen to yours. Fifteen years of FDA study is long enough.  A black box warning for all ages is overdue and will save lives like Woodys.



Eric Swan