2006N-0414
  

  
Suicidality Data from Adult Antidepressant Trials
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC36
  



  

  
Submitter : 
  

  
Mrs. Cynthia Schilf
  

  
Date & Time: 
  

  
12/01/2006 09:12:45
  



  

  
Organization : 
  

  
Mrs. Cynthia Schilf
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 In November, 2004, our 16 year old son had shown increasing signs of depression.  We made an appointment with our family doctor, a general practitioner with no specific training in depression or mental disorders.  In that appointment our son reported that he had had no thoughts of hurting himself or committing suicide.  We were sent home with a little brown bag with samples of Cymbalta sufficient for four weeks, without a prescription, with instructions to return for a check up in three weeks.  There was no discussion of the dangers of increased thoughts or risk of suicide in that 10 minute appointment.  In fact, the doctor dismissed the significance of any link between antidepressants and suicide.  There was no discussion of warning signs to observe or instructions to call immediately if the warning signs were exhibited.  There were no package inserts describing the product or giving warnings in the sample boxes.  The drug was not FDA approved for use in minors.



We kept the three week check up appointment, in which our son was given a prescription for the same drug.  Since he had one week of samples remaining, we didn't refill the prescription right away.  Peter committed suicide one week later, exactly four weeks after beginning Cymbalta.



It is our strong belief that as parents we were inadequately warned of the dangers of antidepressant drugs, even though at the time our son was given these drug samples the black box warning was being drafted and was published a month later.  The drug was distributed as samples, just a few months after being marketed for depression.  The drug was distributed by a doctor without specific knowledge in the field of depression, or about the pending black box warning for this and similar drugs.  The drug was distributed without any package inserts giving warnings.  Not until after our son's death did we hear information regarding the dangers of antidepressant drugs.



We feel this type of drug should be more closely controlled, not distributed freely as samples.  Had we been given a prescription to be filled by a pharmacist instead of samples, we would have been provided better information.  We trusted our doctor to give us appropriate treatment.  The doctor was influenced by the easy availability of the drug, and we lost our son.