2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7090
  



  

  
Submitter : 
  

  
Mrs. Ellen Thompson
  

  
Date & Time: 
  

  
03/06/2006 10:03:20
  



  

  
Organization : 
  

  
Mrs. Ellen Thompson
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 My name is Ellen Thompson and I have been taking bio-identical hormones since April of 2004.  It has been a tremendous comfort to me as it has reduced the severity of several ongoing medical issues such as headaches (including migraines). 

                                          

I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them.  Without this medication, I would suffer from various side effects (





___________________________________________________________.

(Describe how you would suffer or how your life would be more difficult without the medication.)

 

 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,





My physician has put me on compounded hormone replacement therapy. At different stages of diagnostic tests, he has continued to monitor carefully the hormone levels. I have felt so much better since he has reduced the levels. Furthermore, it is nice that the medication can be combined into one pill that serves both needs. 



With the first diagnostic test, it was determined that my estrogen levels were way too high. This in itself can cause medical problems. I have had several ongoing medical issues. Also, the progesterone levels were too high also. With time, my doctor has been able to reduce both of these levels. The gradual reduction of the hormones has generally decreased some of my other medical problems.



Also, I am on a compounded formula for thyroid. It only makes sense that 'one pill fits all' is not an effective methof of treating patients. The medication I buy at Walgreen's is not going to affect me the same way as my neighbor.



The American people need to be able to have a choice as to their medical care. Too many of us are already 'fed up' with the medications that are given to us. Not to mention the side effects! I have had no side effects with the compounded formulas because they are 'tailor made' for me. 



The compounded medications are prescribed and adjusted so a prescription can increase or decrease the medication as necessary. It would be a crime for my doctor not to be able to prescribe 'tailor made' medication for me as he determines.


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 

Furthermore, I think it is quite evident why this drug company would want to petition against pharmacies that compound medications. The pharmacy that tailor makes prescriptions for me is not endangering my health.