Estriol And The FDA

Recently, the FDA sent out warning letters to seven compounding pharmacies across the country with conce
s about the use of estriol. The FDA is allegedly receiving pressure to take action against natural hormones from synthetic hormone producer Wyeth Pharmaceuticals, whose sales of Premarin and Prempro declined billions of dollars over the last couple of years. Estriol has a long-standing United States Pharmacopoeia monograph, an accepted standard for drug ingredients absent significant health risks. Compounding pharmacies and their associations are prepared to respond to the FDA's recent actions and help preserve the individual's choice for natural hormone replacement.

What is estriol?

Estriol is one of the three naturally occurring estrogens in the body. Estriol is much weaker in action than the other estrogens, estradiol and estrone. Estriol has been used extensively in Europe by peri- and postmenopausal women for estrogen replacement therapy. European clinical studies have shown estriol to be effective in the treatment of hot flashes and vaginal dryness. Some studies have suggested estriol has a breast protective effect, possibly reducing the risk of breast cancer. Estriol is available in the United States by prescription filled only by compounding pharmacies. It may be used alone or in combination with estradiol (Bi-est) or with estradiol and estrone (Tri-est).

What are experts saying about estriol?

"Estriol does not cause excessive cell growth in the uterine lining or breast tissue, and has been shown to have equal benefit for the skin collagen layer as the other estrogens."
Christiane Northrup, M.D.
Womens Bodies, Women's Wisdom

"I will continue to prescribe estriol as an important part of the total hormone replacement therapy for my patients -- whom I have found to benefit from its use."
Cheryle Hart, M.D.
Mayo Clinic trained OB/GYN, Founder of Hormones by Hart
Press Release 1/16/08

"Estriol is a human hormone produced by the human body. It is one of the three estrogen molecules and the most abundant during pregnancy. Women who cannot tolerate estradiol may use estriol. Like many commonly prescribed drugs (e.g. quinine, Phenobarbital), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded."
Erika Schwartz, M.D.
Author of The Natural Hormone Solution, Co-founder of Bioidentical Hormone Initiative.

I hope this clears up some of the confusion regarding this controversial action by the FDA.