2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | |||||||||||||||||||||||
FDA Comment Number : | EC223 | |||||||||||||||||||||||
Submitter : | Ms. Julie Cline | Date & Time: | 01/26/2006 08:01:41 | |||||||||||||||||||||
Organization : | Ms. Julie Cline | |||||||||||||||||||||||
Category : | Individual Consumer | |||||||||||||||||||||||
Issue Areas/Comments | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
RE:2005P-0411 - My right to bioidentical hormones prescribed by my physician and filled by my pharmacist is being threathened. I am a 59- year-old woman who
has used bioidentical progesterone for 4 years and low doses of bioidentical estrogen for almost 2 years.They are prescribed in doses individual to my needs and filled at my local compounding pharmacy. These prescriptions have stopped the symptoms of profound exhaustion, muscle problems, inability to sleep, extremely sore breasts and hot flashes. I know that as my body changes they can be incrementally adjusted to suit my symptoms and test results. I have resumed my life of hiking, downhill skiing, traveling, and being an active grandparent. I no longer sit in front of a TV wondering how I will get the energy to go to the grocery store or to even to think. Wyeth is trying to insert itself between my physician and me in an attempt to promote its synthetic product that has few doseage alternatives and often has side effects. | ||||||||||||||||||||||||