2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2842
  



  

  
Submitter : 
  

  
Mrs. Keli Stoddard
  

  
Date & Time: 
  

  
02/16/2006 04:02:43
  



  

  
Organization : 
  

  
Mrs. Keli Stoddard
  



  

  
Category : 
  

  
Drug Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am 48 years old, and for the past 9 years I have been under my dr.'s care using bioligically identical hormones...specifically testosterone and progesterone. I had been on years of antidepressents, and it finally took a caring doctor who looked deeper and found that hormone imbalance has been the issue. We discussed how the hormones are absorbed into the skin, and I had immediate relief from symptoms that plagued me for years. In addition to treating the depression, testosterone eliminated problems I was having with clouded thinking, incontinence, and sleep deficiency. The progesterone has helped with breast soreness, fluid retention, mood swings (my family is grateful). We discussed the WHI studies, and unfortunately, I believe the public has not carefully read those studies to see what was really found. But as far as I am concerned, because Premarin and Prempro are taken orally, the gi tract is not going to recognize those substances as natural to what should be in the stomach, and there will be side effects and absorption issues. Getting the biologically identical hormones right into the system through skin absorption is highly effective.

Because Wyeth doesn't like the bad press they have received and sales have dropped, does that warrant taking off the market the products that have helped so many of us? Wyeth could get on the band wagon with what people are finding works. 

Compounding pharmacies have provided a much needed and valuable service. My compounding pharmacy holds seminars and will personally meet with me to discuss my symptoms and work with the dr. in finding the right balance of hormones. Please DO NOT take away a treatment option for me that has worked. Replenishing my body with the needed hormones that my body cannot make has eliminated the need for me to take other medications. I feel we are reaching the root of the issues rather than slapping lots of meds at a multitude of symptoms.

Please protect my right to work with compounding pharmacies and use biologically identical hormones. Please let our free market economy fuction in its purest sense without limitations because Wyeth sales have fallen.