2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC1891
Submitter : Mrs. Shera Ainsley Date & Time: 02/13/2006 04:02:37
Organization : Mrs. Shera Ainsley
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I am currently benefiting from prescription strength bioidentical hormones prescribed by my physician and prepared from a compounding pharmacy.I have tried several synthetic hormones in the past and had very undesirable side effects with minimal benefits. My quality of life has improved dramatically with the use of the bioidentical hormones. As a citizen of the United States I would like to see the FDA stand up for my rights and the rights of all women who have found consistent, safe and effective treatment with bioidentical hormones. Eliminating options is not in the public interest and would deprive hundreds of thousands of American women from access to bioidentical hormones. Synthetic hormone replacement has been proven unequivocally unsafe in a government sponsored study and should not be forced as the sole treatment option for women. I hereby request the FDA rule against Wyeth's request and ask for more information on the safety of the Wyeth synthetic hormone