2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC230
  



  

  
Submitter : 
  

  
Mrs. Susan Schuessler
  

  
Date & Time: 
  

  
01/26/2006 08:01:33
  



  

  
Organization : 
  

  
Mrs. Susan Schuessler
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir or Madam:

     My name is Susan K. Schuessler and I have been taking bio-identical hormones for 2 1/2 years. It has been a tremendous comfort to me as it alleviates miscarriages.  I consult with my physician, who prescribes bio-identical hormones specifically for me and my pharmacist prepares them. Without this medication I would not have become pregnant and able to carry a child full term.  I was on progestrone capsules to conceive and after two miscarriages was put on progestrone injections and Norvarel (HcG hormone) injections to continue the third pregnancy.  So far I am in my sixth month and hope to deliver a healthy baby in April, 2006.  I feel that without access to these bio-identical hormones my husband and I would not have the benefit of becoming and staying pregnant.  

     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,

Susan K. Schuessler

Lincoln, NE