2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC2554
Submitter : Ms. Rhonda ODonnell Date & Time: 02/16/2006 11:02:16
Organization : Ms. Rhonda ODonnell
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Docket 2005P-0411 should not be approved. I have been using bio-identical hormones for the past year and it has been the best year I have had since my hysterectomy 13 years ago. I had tried the drug companies' hormone replacement for 12 years and I never felt good during that entire time. In addition, I never slept well and I kept bloating and adding weight during that entire time despite regular exercise. With the bio-identical hormones I am now able to enjoy time with my husband again and am able to lose weight and feel "normal". Please do not take this away from me. My only alternative would be to take nothing at all and that is also not pleasant. I would never take any synthetic hormone again. The difference between the synthetic and bio-identical is that significant for me.