| 2005P-0411 | ||||||||||||||||||||||||
| FDA Comment Number : | EC18 | |||||||||||||||||||||||
| Submitter : | Mrs. Sheila Sorensen | Date & Time: | 12/19/2005 01:12:37 | |||||||||||||||||||||
| Organization : | Mrs. Sheila Sorensen | |||||||||||||||||||||||
| Category : | Individual Consumer | |||||||||||||||||||||||
| Issue Areas/Comments | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| Dear Sir or Madam:
My name is Sheila Sorensen and I have been taking bioidentical hormones for seven months. It is been a tremendous comfort to me as it alleviates negative symtoms associated with uturine fybroids. I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, my periods were unbearable, and the fibroids in my uterous may prevent pregnancy. The benefit of BHRT is that it is designed for me and I am concerned that Wyeth's petition (DOcket # 2005P-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, Sheila Sorensen Santa Rosa, California | ||||||||||||||||||||||||