2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC195
  



  

  
Submitter : 
  

  
Mrs. Rebecca Ritch
  

  
Date & Time: 
  

  
01/26/2006 08:01:30
  



  

  
Organization : 
  

  
Mrs. Rebecca Ritch
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I have been taking bio-identical hormones for 3 1/2 years.  It has been a tremendous comfort to me as it alleviates restlessness at night, hot flashes, clears my thinking and coping abilities and other symptoms I have had over the past years.  I consult with my physician at my yearly check and she prescribes bio-identical hormones specifically for me and my pharmacist prepares them.  My physician first prescribed Premarin which I took for 3 months.  My feet began to swell out over my shoes and I could not see the benefits that I have had taking bio-identicalhormones.  I have had no side effects. I bought a book and read about bio-identical hormones and talked with my physician and she agreed that I should try them.

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,

Rebecca Ritch

Lenoir, NC