2005P-0411

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

FDA Comment Number :

EC7414

Submitter :

Ms. Vicky Merrifield

Date & Time:

03/06/2006 03:03:22

Organization :

Ms. Vicky Merrifield

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

I am writing this letter with the fear that my bio-identical hormone replacement therapy may not be available to me in the future. When considering a hysterectomy in 2004, my biggest concern was hitting menopause. As my mother and grandmother both had breast cancer, I refused to go on the typical estrogen replacement. My doctor, understanding my concern recommended trying bio-identical therapy. It has been a year and a half now, my doctors keep an eye on my hormone levels through blood tests, and have made a couple adjustments in my prescription in order to keep me at a level of hormones to not experience any menopause symptoms as well as alleviating any concerns about my medication causing cancer and bone density loss. If bio-identical were not available, I would not switch to prescription hormones but instead would face menopause without any medications. I feel very strongly that the choices offered by the big drug companies are not healthy and cause too many side effect.

Please do not fall under the pressure from the large pharmaceutical companies. Bio-identical compounds do work. Not only that, the companies who produce them, work for me. They listen to me personally (I have spoken to a pharmacist two or three times), as does my doctor, and together we come up with a plan for making changes to help me. The alternative hormone replacement therapies are "one size fits all". That doesn't work for me in clothing, and it certainly doesn't work for me with my medication! Vicky Merrifield