2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC219
  



  

  
Submitter : 
  

  
Ms. Kathleen Reynolds
  

  
Date & Time: 
  

  
01/26/2006 08:01:27
  



  

  
Organization : 
  

  
Ms. Kathleen Reynolds
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir or Madam:

 My name is Kathleen Reynolds and I have been taking bioidentical hormones for

about 1 year. It has been a tremendous comfort to me as it alleviates most 

menopausal symptoms such as hot flash,insomnia,anxiety and some depression.

 I am a nurse and I consult with a physician who listened to my symptoms, performed blood tests and prescribed bioidentical hormones specifically for me and my pharmazcist prepares them.  Before this medication, I felt like my life as a woman was over as I found it difficult to function comfortably. Hot flashes and insomnia take their toll after  months of discomfort and work and quality of life suffers.

  The benefit of BHRT is that is is designed for me and I am concerned thta Wyeth's petition (Docket # 2005P-0411) would limit the ability of my physician

to prescribe and my pharmacist to prepare these individualized doses for me. I urge the FDA to reject Wyeth's petition.



   Sincerely,

   Kathleen Reynolds, RN