2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7451
  



  

  
Submitter : 
  

  
Mrs. Deanne Black
  

  
Date & Time: 
  

  
03/06/2006 04:03:03
  



  

  
Organization : 
  

  
Mrs. Deanne Black
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
  My name is Deanne Black and I have been taking bioidentical hormones for two years. It has been a tremendous comfort to me as it has allevitated migraine headaches that otherwise occured when taking synthetic hormones.

  I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, I fear I would need to return to synthetic hormone replacement and thus once again be plagued with migraine headaches. These are debilitating headaches that require expensive medication and time off work.

  The benefit of BHRT is that 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,

Deanne Black

Bastrop, LA