2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | |||||||||||||||||||||||
FDA Comment Number : | EC7007 | |||||||||||||||||||||||
Submitter : | Mrs. Billie Stallings | Date & Time: | 03/06/2006 09:03:29 | |||||||||||||||||||||
Organization : | Mrs. Billie Stallings | |||||||||||||||||||||||
Category : | Individual Consumer | |||||||||||||||||||||||
Issue Areas/Comments | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
My name is Billie Stallings and I have been taking bioidentical hormones for 2 years. They have been a tremendous comfort to me relieving me of hot flashes, night sweats and terrible mood swings. My doctor recommended that I take the natural hormones rather than the synthetic due to my age (53), history of cancer and heart risks in my family. I would not be able to function without taking the bioidentical hormones nor would I feel as good as I do on a daily basis without them.
The benefit of BHRT is that it is designed for me. I am concerned that Wyeth's petition (Docket #2005P-0411) will limit the ability of my doctor and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should REJECT Wyeth's petition. | ||||||||||||||||||||||||