2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7437
  



  

  
Submitter : 
  

  
Ms. Ruth Rooks
  

  
Date & Time: 
  

  
03/06/2006 03:03:50
  



  

  
Organization : 
  

  
Ms. Ruth Rooks
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 



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RE: Docket 2005P-0411



Dear Sir or Madam:



 My name is Ruth Ann Rooks and I have been taking bio-identical hormones for 9 years.  It has been a tremendous comfort to me as it alleviates depression, weight gain, hot flashes, and other symptoms of midlife hormone depletion.

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 take Premarin, which is made from horse urine and which contains the types of estrogens in the proportion appropriate to a horse.

Since I am not willing to risk breast cancer by taking Premarin, I would have to go off HRT, and I would have a much more difficult time dealing with the depression that would result. 



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,

Ruth Ann Rooks