2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2520
  



  

  
Submitter : 
  

  
Ms. MaryAnn Gamel
  

  
Date & Time: 
  

  
02/15/2006 04:02:19
  



  

  
Organization : 
  

  
Ms. MaryAnn Gamel
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am both a consumer of compounded bio-identical hormone replacement as well as a health care professional.I have taken these bioidentical hormones for over two years with not adverse reaction as the ingredients are identical to the hormones found in women's bodies. In fact, I have noticed a decrease in fibrocystic breast tissue since I have been on these hormones.



Prior to starting bio-identical hormone replacement, I took both Prempro and Premarin. I discontinued them after the results of the Women's Health Study came out. I was not on any form of hormones for about 6 mos when I learned there were other options besides synthetic hormones made from pregnant mare's urine. As an animal lover, I find it appalling the way these mares are treated to enable Wyeth to collect their urine to be used in the manufacture of Premarin and Prempro.



After being off hormones for 6 mos, I found I continued to have hot flashes, muscle and joint aches, increased fatigue, decreased libido, and vaginal dryness. The last two symptoms were also experienced while taking premarin and prempro.



When I learned of a seminar on alternatives to Prempro and Premarin led by one of the local physicians, I attended that meeting. I was intrigued by what this physician had to say, and immediately scheduled an appointment with her.



After three months on bioidentical hormones, all the abovementioned symptoms had resolved. It is my plan to continue taking bio-identical hormones until I die as I really do not see how a hormone that is natural to your body can be harmful to you.



Thousands of women across U.S. take bio-identical hormones. These women have a much better quality of life than they did before they started taking these hormones. I urge you consider this action very carefully and realized that Pharmacies compounding bio-dentical hormones are not in flagrant violations of the law and that these drugs do not endanger public health.



Sincerely,

MaryAnn Gamel, MSN, RN, FNP, BC