2008-Women in Balance
FDA threatens your rights to
have health care choices you need to balance your life
At Women in Balance (WIB) we want you to
be informed about issues that affect your health choices. Please
read and share the following information with your friends and
WIB is dedicated to providing factual and unbiased information, so you
can make decisions about your own health. Action by the FDA
on January 9, 2008 seriously threatens your future ability to obtain
individualized hormone therapy. WIB wants you to know the points -
and facts - of this action, so you can get involved and have your voice
FDA issued warnings to seven compounding pharmacies, declaring that use
of the term bio-identical (natural) hormone therapy (BHRT) is a term not
recognized by the agency and should not be used to market compounded
hormones, nor can claims be made that these compounds are better and
safer than "FDA approved" hormone containing drugs. And of most
concern is that the hormone estriol, (being used in 80% of compounded
hormones for menopause) is not recognized as safe by FDA, as this
compound is not currently found in any "FDA approved" hormone containing
Here's our take on FDA's key points
Compounding pharmacies cannot
include estriol, a main ingredient in many compounded hormone
prescriptions, since the FDA has not approved any commercial
drugs containing estriol.
Estriol is a very mild estrogen. It is one of the three
estrogens natural to a woman's body, and the main estrogen during a
pregnancy - the fetus is bathed in it.
Estriol is primarily used in cream form for vaginal dryness and
urinary problems for women in perimenopause and menopause.
FDA recognizes that individually compounded medications should be
available to patients (by prescription) for "those drugs for which
no FDA approved option exists". There is no FDA approved drugs
containing estriol, so it is a perfect example of where a compounded
prescription would be needed in select cases.
FDA claims that there is no safety and patient response data for
estriol. In fact there is a body of literature about this
which can be accessed in the Research section on the Women in
Estriol has been used in Europe and Japan for years with no reported
Like many commonly prescribed drugs, estriol has a monograph from
the U.S. Pharmacopeia (USP), the ingredient compendium that sets the
national standards for compounding medicines.
Action: The terms "bio-identical hormone
replacement therapy or BHRT" are considered marketing tools with no
medical or scientific basis.
"Bio-identical hormone" is a term in wide use
today, and has a very clear definition and meaning. It simply
refers to the chemical structure of a hormone molecule being
identical to the hormone molecule found in humans.
North American Menopause Society held an all day conference titled
"Understanding the Controversy: Hormone Testing and Bio-identical
Hormones" in October 2005.
manufacturer of FDA approved hormone products accurately promote
their drugs as being "bio-identical" in their literature and on
their websites (www.prometrium.com and www.estrogel.com). Will
the FDA begin sanctioning these companies as well?
Compounding pharmacies cannot claim in their promotional materials that
compounded bio-identical hormones are safer or more effective than
hormones approved by the FDA.
FDA must protect the public from fraudulent and misleading claims
with potentially dangerous drugs and foods.
Pharmacies and pharmaceutical companies making unwarranted claims of
safety and efficacy should indeed be sanctioned.
Women have a right to choose their
treatment when multiple options exist, and practitioners have a right to
prescribe drugs to benefit each individual patient. In the absence
of observed and documented danger of a compounded prescription,
the FDA should not interfere in the doctor-patient-pharmacist
We will be monitoring this situation over the weeks to come and will
provide actions steps you can take to make your voice heard on this
At WIB, we believe women have a right to accurate, unbiased information
and resources to help them through the often tumultuous transition at
menopause. As part of our educational mission, we will soon release a
thoroughly documented scientific paper; The State of the Science of
Bio-identical Hormones. This publication is made possible by
your generous support. Please join WIB today and receive a copy of
this important publication in the near future. Go to
www.womeninbalance.org or click
"Support the Cause".
Women In Balance