2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7481
Submitter : Ms. Patricia Moore Date & Time: 03/06/2006 04:03:30
Organization : Ms. Patricia Moore
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Dear Sir/Madam - My name is Patricia Moore and I have been taking bio-identical hormones for about 3 months. It has been a tremendous comfort to me as it greatly reduces the frequency and intensity of the hotflashes and other symptoms associated with surgically induced menopause. I consult with my physician who prescribes bioidentical hormones specifically for me and my pharmacist prepares them. Without them, my hormone balance would be out of whack, I would experience hotflashes on an hourly basis (at the minimum). I'm 38 years old and am VERY pleased with the results of the BHRT my doctor has prescribed. The benefit of BHRT is that it is designed for me and I am concerned that Wyeth's petition (Docket #205P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should reject Wyeth's petition.
Sincerely,
Patricia Moore
Tampa, FL