2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7228
  



  

  
Submitter : 
  

  
Ms. Leih Merigian
  

  
Date & Time: 
  

  
03/06/2006 01:03:56
  



  

  
Organization : 
  

  
Ms. Leih Merigian
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I have been taking bio-identical hormones for 4 years.  It has been a tremendous comfort to be as it alleviates the many symptoms I was experiencing, including constant hot flashes, extreme mood swings and depression.  



I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them.  Without this medication, I fear a return of the terrible mood swings and constant hot flashes that plagued me prior to taking this critical medication.  I am disabled and live with constant chronic pain and fatigue, and it is incredibly difficult for me to have to deal with more symptoms than I already must deal with on a daily basis.  I must have my bio-identical hormones!



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,

leih merigian