2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC306
  



  

  
Submitter : 
  

  
Mrs. Monica Luedecke
  

  
Date & Time: 
  

  
01/26/2006 02:01:01
  



  

  
Organization : 
  

  
Mrs. Monica Luedecke
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 

Bio-identical hormones are an essential ingredient to my health and to the health of women like me, in their mid 40s and older, who desire to live a productive, healthy, and vibrant life.  For me, there is no other option.  Wyeth has committed an unpardonable act by attempting to portray bio- identical hormone therapy (BHT) as unsafe when in fact, it is an extremely safe option for women. Their drugs, Premarin and Prempro, which were studied in the Women?s Health Initiative, and FDA approved, are fraught with harmful, even deadly, side effects for women. Shame on them for this greedy and deceitful attack on the compounding pharmacy industry!  And, shame on the FDA if you let yourself be used as a patsy by Wyeth in order to eliminate competition in the marketplace.  I have a right, as do all women, to be able to continue to enjoy a healthy transition into menopause and beyond through the use of bio-identical hormones. I have taken these since 1996, I have always obtained them from a compounding pharmacy, and have enjoyed all the benefits therein.  It would be greatly appreciated by me, one woman speaking on behalf of many, if you would dismiss Wyeth?s complaint against the compounding of bio-identical hormones and instead, review the information on Premarin and Prempro, and recall those drugs from the market.