2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC34
  



  

  
Submitter : 
  

  
Ms. Mary Miles
  

  
Date & Time: 
  

  
12/01/2006 09:12:07
  



  

  
Organization : 
  

  
Ms. Mary Miles
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
  Thank you for giving me the opportunity to tell you about a terrible tragedy that happened to our family. The death of my husband Bruce Miles.



 Bruce E. Miles graduated from Auburn University with a degree in Chemical Engineering in 1978.  After graduation he accepted a job with Dow Chemical in Louisiana.  We got married on July 5, 1980.  To further his career Bruce decided to get a MBA from LSU.  With a degree in Chemical Engineering and a MBA he gradually progressed through the ranks at Dow, ultimately becoming a Senior Production Leader with the Chlorinated Organics Manufacturing plant. Bruce was always rated superior in performance and was well liked by the Dow administration. This job was demanding and caused some stress. He carried these feelings about his job for several months before going to see his doctor, Dr. Minsky, a Family Practice Doctor.  He made an appointment to see Dr. Minsky on August 16, 2002.



After his visit with Dr. Minsky Bruce told me that he was diagnosed  adjustment anxiety to his new job. Dr. Minsky gave him free samples of Zoloft 

( 7 bottles with 7 pills 50 mg each) and told him to take 50 mg per day.  Dr Minsky also told Bruce that this medication would be temporary and that in approximately 6 months he could easily quit taking this medication. 



 Bruce started taking Zoloft on Friday August 16,  and after a few days he started complaining of restlessness.  He was having trouble sleeping.  He could not settle his body down, he felt edgy.  He called Dr Minskys office to report the problem. At around 5:00 pm on Wed. August 21, he received a call from Dr. Minskys nurse.  The nurse told Bruce that Dr. Minsky wanted him to increase the Zoloft dosage to 100 mg.  On Thurs. Morning he increased his Zoloft dosage to 100mg.



 Friday morning August 23, 2002 Bruce got up, took his medication, and left for work.  At around 10:30 am Bruce called me at work.  He told me that he was feeling very ill.  I was concerned because he usually is never sick.  He sounded terrible.  He said that he felt physically ill.  He described his head as feeling numb.  He was very concerned about this feeling.  He told me that he could not think and that his mind was blank. He said that he never felt this way before.  He said that he was going to take a half day and go home. I asked him if he thought it was the medicine that made him feel sick.  He said he did not know. 



 I left work and made it home by 12:15 to check on Bruce.  I noticed Bruce had arrived already and searched the house for him.  To my dismay, I found him in the guest bathroom.  He had already taken his life, with his handgun, a single shot to the forehead.  I immediately called 911 and attempted to apply CPR but it was to late.



 Bruce was a man that was in good physical shape and enjoyed life.  At 45 he seldom ever was sick, never taking prescription medicine.  He had no prior history of depression.  His visit to the family Doctor was for Adjustment Anxiety to his new job. He had no suicidal ideation at the time of his visit. He was very concerned with prolonging his life.  He underwent yearly physicals. He did all these things to remain healthy.



 Bruce was a wonderful husband of 22 years and father of two beautiful children.  He enjoyed working on his home, jogging, camping with his

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 sons boy scout troop and was a 6 handicap golfer.  He was a devout Catholic.  He had good faith, family, friends, health, job and financial security. We were extremely close and communicated freely with each other. Bruce never gave me any indication that he was suicidal or was having suicidal thoughts. There was abosolutely no motive for him to end his own life intentionally. We were very happy.

On Aug.23 2002 I had no indication that his life would end. He left no note my children and I were in complete shock. I truly believe Bruce had an adverse reaction to the antidepressant he was prescribed. If he was not taking Zoloft he would be alive today.