2005P-0411

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

FDA Comment Number :

EC2481

Submitter :

Mrs. Janet Miller

Date & Time:

02/15/2006 04:02:30

Organization :

Mrs. Janet Miller

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

To Whom it May Concern:

It has recently come to my attention that Wyeth is attempting to persuade the FDA to cut off access to Bioidentical hormones from compounding pharmacists.. I have been on HRT since 1994. I took Premarin and Prempro for over ten years. The .625mg pill of Premarin caused me to have huge breast lumps, which were very frightening. When I reduced the dosage to .3mg the breast lumps went away, but the dosage was not strong enough to prevent vaginal atrophy. This condition continued to get worse. I was given Estrace vaginal cream, which helped with the atrophy , but caused me to hemorrhage because of fibroids. It also caused insomnia. I had to have a hysteroscopy to check for uterine cancer because of the bleeding. Then I was given Vagifem vaginal tablets, which again helped the atrophy and pain, but caused heavy bleeding and insomnia again. I had to go through another hysteroscopy for vaginal bleeding. I have been to 4 different gynecologists to find relief from this problem. The fourth doctor recommended a hysterectomy and a vestibulectomy. The plan was to then be able to use Estrace or Vagifem. Without the uterus I would not experience bleeding. The vestibulectomy was very painful. Then we tried, Estrace, then, Vagifem, and then Premarin vaginal cream. All of them caused insomnia, anxiety, and depression. I had been suffering from anxiety, depression , and insomnia since 1997, but I had never associated it with HRT. Then it was suggested that I try compound BHRT. After several different compounds it became obvious that I could not tolerate estradiol, which is in Estrace, Premarin cream, and Vagifem tablets. I could not use biest, progesterone, or testosterone cream used as a topical cream or a vaginal cream. It took several weeks with many unpleasant side effects before it was discovered that I could use estriol. I have been using estriol compounded vaginal cream for 5 months. The vaginal atrophy and intense burning are gone. My anxiety and depression have improved. I am sleeping better than I have for years. The vaginal burning and atrophy was preventing me from sitting in church, concerts, or meetings. I had to buy very loose fitting slacks that would not rub against the area. At home I would only wear a night shirt and underwear because any other clothes would make it hurt worse. I couldn't ride in a car very far, ride a bike or exercise equipment at all. Taking walks, sexual activity with my husband, swimming (because of the chlorine), and playing with my grandchildren were too painful to do. The estriol cream has given me my life back. It is not available anywhere, except through a compound pharmacy. I have to drive some distance to get it and I must pat a higher copay for it on my drug card. Since using estriol I have found out that many of my friends also use Bioindentical hormone replacement therapy. Their stories sound very similar to mine. It was the only thing that they could tolerate.I believe if there were more women involved in the decision making process of using HRT or BHRT the outcome of these decisions would be different. Imagine your wife, mother, daughter, or other female friends going through the torturous pain I have experienced for so long. Then imagine finally finding a cure and then being told it was no longer available or that it was going to be more expensive or more difficult to get. Estrone and estradiol are both know carcinogens, but the drug companies still put them in their products. Estriol is a natural hormone and has been shown to help prevent cancer. I recommend reading these books: HRT: The Answers by Pamela Warlian Smith MD and Natural Hormone Replacement by Johnathan V. Wright MD. Please don't allow this option of treatment to be taken away!!!