2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7457
  



  

  
Submitter : 
  

  
Ms. Linda  McNulty
  

  
Date & Time: 
  

  
03/06/2006 04:03:34
  



  

  
Organization : 
  

  
Ms. Linda  McNulty
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I have been taking bio-identical hormones for 7 years.  It has been a tremendous benefit for me as it alleviates menopausal symptoms of hot flashes and night sweats.  I consult with my physician who prescribes bio-identical hormes specifically for me, and my pharmacist prepares them. Without this medication, my life would be intolerable. I have a long history of migraines, endometriosis and recently developed polycythemia vera (a form of blood cancer).  I do not want to use Premarin or Prempro which are patentable synthetic versions of the hormones that naturally occur in women's bodies. I have tried both of these drugs in the past and do not like the side effects. Both drugs made my horrible migraines even worse. My HRT 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 individual doses for me. The FDA should reject Wyeth's petition.