2005P-0411

Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

FDA Comment Number :

EC2469

Submitter :

Mrs. Kathleen McMurry

Date & Time:

02/15/2006 04:02:53

Organization :

Mrs. Kathleen McMurry

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

My name is Kathleen McMurry. I a mother of two children, age 17 and 20, and I am 54 years old. I have been taking bioidentical hormone replacement therapy (BHRT) since I went into perimenopause in 2001, and I have found them particularly useful since I began menopause this year. I take bioidentical hormones for multiple conditions: they kept me from having to have a hysterectomy for terrible symptoms of adenomyosis (hemorrhagic bleeding and pain), and prevented standard perimenopause and menopause symptoms such as mood swings and fatigue. Standard HRT not only did not help with these symptoms, it made them worse.

In addition, BHRT helps protect me from osteoporosis. I have osteopenia due to a family predisposition and from being on thyroid for the past five years for hypothyroidism. I have a specific type of osteopenia that research shows most profits from HRT to keep it from advancing to osteoporosis, but recent research findings have caused the medical establishment to deem conventional HRT too dangerous to the heart to take for more than a few years. In addition, in my specific case, conventional HRT made up of laboratory synthesized progesterone (progestins) and estrogens makes me nauseous and creates a 7-pound weight gain of abdominal edema. I am also unable to take the alternatives to HRT for osteopenia, such as Fosamax, because they, too, give me unacceptable gastrointestinal disturbances.

I consult with my physician, who prescribes bioidentical hormones specifically for me, and my pharmacist, who prepares them. Without this medication, I would have to suffer from menopausal symptoms, and be at great risk for requiring a hysterectomy for adenomyosis. I would also be at much greater risk for advancement of my present osteopenia to full osteoporosis, which is a major illness that involves intense pain and suffering as well as drastically reduced mobility.

BHRT is a safe medication that provides enormous benefits. I am concerned that if Wyeth?s petition (Docket #2005P-0411) were approved by the FDA, it would limit the ability of my physician and pharmacist to keep prescribing and preparing individualized doses of a drug that is of enormous benefit for my health.

Please reject Wyeth?s petition.