2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7350
  



  

  
Submitter : 
  

  
Ms. Kathleen White
  

  
Date & Time: 
  

  
03/06/2006 03:03:31
  



  

  
Organization : 
  

  
Ms. Kathleen White
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I have been taking bio-identical hormones for more than two years.  It has been a tremendous relief to me as it alleviates the 20 or more hot flashes I was having day and night, which interfered with my work performance, and caused me miserable, sleepless nights.



I have tried the commercially available progesterone preparations but had 

multiple side effects with Progestin and find that the bioidentical formula of progesterone available commercially, Prometrium is too strong for me.  For whatever reason, I tolerate only a smaller amount of this drug at a time than is commercially available.  Using a compounding pharmacy I am able to get smaller sized doses that I use more frequently.   



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.