2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2839
  



  

  
Submitter : 
  

  
Miss. Diane Smith
  

  
Date & Time: 
  

  
02/16/2006 04:02:15
  



  

  
Organization : 
  

  
Miss. Diane Smith
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I was introduced to bio-identical hormones by Dr. Steven Hotze following months of irregular menstruation and unusually heavy blood flow. Desiring to avoid the increased chances of breast cancer, blood clots to the lungs, heart attacks and strokes incurred by persons taking synthetic hormones, such as Premarin and Prempro, I chose to follow Dr. Hotze's plan to take Bio-identical Progesterone, Testosterone, Cortisol and Armour Thyroid.



Following 3 years of regular prescription refills for these Bio-identical Hormones, I am pleased to report no side effects whatsoever.  With respect to my initial problems, I have resumed regular menstruation and only normal blood flow at age 49, and benefit from dramatically increased energy and enthusiasm for life.



I consider Bio-identical Hormones to be completely safe when taken by mouth.  My physician regularly monitors the levels of hormones in my blood and adjusts my prescriptions, when needed.  Of course, no drug should be administered without a physician?s order.  I object to this attempt by Wyeth to restrict a patient's right to choose to use a safe, effective, natural treatment, such as Bio-identical Hormones.



I believe the 2002 Women's Health Initiative was a valid examination of Wyeth?s products, Premarin and Prempro, and this Case (Docket 2005P- 0411) is Wyeth's lame attempt to bolster sales of its harmful products.  Please dismiss this Case as having no merit.