2005P-0411
  

  
 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs 

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2732
  



  

  
Submitter : 
  

  
Mrs. Karen LaPlant
  

  
Date & Time: 
  

  
02/16/2006 03:02:20
  



  

  
Organization : 
  

  
Mrs. Karen LaPlant
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
  My name is Karen LaPlant and I have been taking bio-identical hormones for 8 months now.  It has been a tremendous comfort to me as it alleviates my symptoms of early menopause.  I feel and act like a new and much younger person than before.

 I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them.  Without this medication, I would have to go back and live my life without them.  For five years I tried synthetic hormones and as a result had several breast biopsies due to negative annual mammograms.  Since I stopped the synthetic hormones and started taking bio-identical, I have had all positive test results.  My energy level is up and my family and friends say I am so much happier.  I exercise regularly and seem to handle stress better.  I am not yelling at anyone!

 The benefit of BHRT is that it is designed for me and I am concerned that Wyeth's petition (Docket # 2005P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized doses for me.  The FDA should reject Wyeth's petition.



Sincerely,



Karen LaPlant