First Estriol, Then What?
According to an article written by Loyd V. Allen, Jr., PhD, RPH, Editor-in-Chief of the International Journal of Pharmaceutical Compounding, the United States Food and Drug Administration (FDA) has taken action to halt the compounding of hormone preparations that contain estriol, an action requested in a citizen petition filed by Wyeth Pharmaceuticals, maker of Premarin products.
Despite the fact that estriol is produced naturally by the body and is responsible for normal growth changes and sexual characteristics, the FDA is “banning” its use. Let’s look at some “facts”:
1. Estriol is a natural hormone produced by the human body.
2. Women’s bodies have been producing estriol throughout human history.
3. Estriol has been commercially marketed in the
4. Estriol has a United States Pharmacopeial (USP) monograph.
5. Estriol is marketed in numerous countries throughout the world.
6. Estriol has been marketed in other countries for over 40 years.
7. Estriol has NOT proven to be unsafe; indeed, quite the contrary.
8. Estriol has NOT been proven to be ineffective; again, quite the contrary.
9. Wyeth markets commercial products containing estriol in other countries throughout the world.
10. Research studies are ongoing in the
11. The FDA has not received any adverse event reports related to estriol.
In summary, if estriol were dangerous and if estriol were ineffective, prescribers or pharmacists would have a problem discontinuing its use. However, that is not the case. The FDA has refused to provide scientific documentation to members of Congress or to healthcare professionals for basis of its decisions. This is not the way the FDA should work. Its decisions must be rational and be based on the prevailing evidence Dr. Allen believes. The FDA should … withdraw its flawed and baseless ban, and allow estriol to be made available to patients.
If the FDA is successful in curtailing the use of estriol … the obvious question is, “what’s next?”
(To read the complete article see page 284, International Journal of Pharmaceutical Compounding, Vol. 12 No. 4; July/August 2008)