The Debate - HysterSisters

W O M E N ’ S
H E A LT H
B U L L E T I N :
The
Bioidentical
ESTROGEN THERAPY (ET)
Debate
IF YOU’RE CONSIDERING ET
to help control your moderate to severe hot
flashes, night sweats, and vaginal atrophy and dryness associated with
menopause, you’ve probably heard the term “bioidentical.” In recent
Inside you’ll find more
information on current
topics including:
years, women have been inundated by the term in the news, through
magazine articles, on television talk shows, or even from their friends.
But, many women just like you are still wondering:
What does “bioidentical ET” really mean?
And what do I need to know about bioidenticals
when I’m choosing my estrogen therapy?
4
Bioidentical ET
Defined
4
Compounding in
Question
4
Sources of
Bioidentical
Estrogen
4
Choosing a
Bioidentical ET
That’s Right for You
The source and form of the estrogen in their
therapy continues to be an important consideration
for most women. But, it’s easy to become
overwhelmed by all the conflicting information
out there about bioidenticals. This resource is
designed to provide you with the facts you need to
know about bioidentical ET and related topics
to help you make an informed decision with
your doctor about what type of ET may be
best for you.
Bioidentical ET Defined
Here are the facts:
ACCORDING TO THE NORTH AMERICAN MENOPAUSE
Products made in compounding pharmacies are not
SOCIETY, the term “bioidentical” is used to describe hormones
subject to the same rigorous oversight and testing as
that are: “chemically identical to the hormones produced
FDA-approved therapies.
naturally by your body.”
There is no scientific evidence that compounded
therapies are safe or effective.
Most major medical associations identify bioidentical estrogen as
estradiol, the most common form of estrogen produced by a
woman’s normally functioning ovaries. Although “bioidentical” is
not a new concept to the medical community, a variety of celebrity
spokespersons and extensive media coverage have recently brought
bioidentical hormones into the women’s health spotlight.
However, many of the same media sources have also misled the
Compounding pharmacies often use combinations of
unapproved hormones, such as estriol, whose safety and
efficacy have not been tested and are not known.
The quality of compounded treatments can vary widely
from batch to batch based on the practices of the
individual pharmacist.
public to believe that bioidentical hormones are only available
Compounded mixtures may not properly be absorbed or
from what’s known as “compounding pharmacies” and that
provide the appropriate levels of hormones needed in
compounded products are safer and more effective than regular
the body.
pharmaceutical medicines.
Compounded therapies are not covered by health
insurance and often come with significant
Compounding in Question
out-of-pocket costs.
“COMPOUNDING” REFERS TO the custom mixing of
It’s important that you talk to your doctor about your treatment
hormones by a pharmacist based on a prescription written by
goals and understand the risks that may be associated with
a physician. This is typically done at a specialty compounding
unapproved treatments before making your ET choice.
pharmacy and can be a good alternative for women with
special needs, such as trouble handling certain components
of drug products.
The practice of compounding has received a lot of media attention
recently that has many women wondering “are compounded
hormones better for me?” Many compounding pharmacies have
claimed that their hormone blends provide natural, safer, and more
effective estrogens than therapies approved by the Food and Drug
Administration (FDA). In January 2008, the FDA issued a series of
warning letters to compounding pharmacies all around the country
stating that these actions “violate Federal law by making false and
misleading claims.”
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus
(womb). Report any unusual vaginal bleeding right away
while you are taking estrogens. Vaginal bleeding
after menopause may be a warning sign of cancer of the
uterus (womb).
Do not use estrogens with or without progestins to prevent
heart disease, heart attacks, or strokes. Using estrogens with
or without progestins may increase your chances of getting
heart attacks, strokes, breast cancer, and blood clots. Using
estrogens with progestins may increase your risk of dementia
(decline in memory and thinking skills).
Please see Important Safety Information on back cover and
accompanying Full Prescribing Information for
Vivelle-Dot® (estradiol transdermal system).
Sources of
Bioidentical Estrogen
The good news is you do not have to go to a compounding
Vivelle-Dot is also one
pharmacy to get a bioidentical estrogen therapy in a range of
of the few estrogen therapies
doses for your moderate to severe menopause symptoms. Many
that offers a low-dose option, 0.025 mg/day,
FDA-approved therapies, like Vivelle-Dot, already contain
approved solely for the prevention of postmenopausal osteoporosis,
estradiol, the form of estrogen identical to your body’s own. For
a major health concern for women after menopause. If you are
women interested in the source of estrogen in their therapy, the
also experiencing moderate to severe hot flashes, night sweats,
estrogen in Vivelle-Dot (estradiol) is chemically derived from a
and vaginal dryness and atrophy associated with menopause,
plant source. This does not mean that Vivelle-Dot is safer or more
Vivelle-Dot has 4 other dosage strengths that can help to control
effective than other estrogen products.
these symptoms while reducing your risk of postmenopausal
osteoporosis—and all under one low co-pay.
The Vivelle-Dot patch is the #1 Prescribed Brand-Name
Bioidentical Estrogen Therapy.*† Vivelle-Dot is a tiny,
Depending on your individual dosing needs, Vivelle-Dot may
translucent, transdermal estrogen therapy that’s applied to the
begin controlling your moderate to severe symptoms associated
lower abdomen twice a week. The patch delivers a continuous
with menopause within 4 hours of application. The patch is proven
flow of estradiol directly into the bloodstream. To help
effective and has been prescribed by physicians for over 10 years.
meet your individual needs, Vivelle-Dot
is available in multiple
strengths so your doctor
can choose the dose
that’s right for you.
Talk to your doctor about whether Vivelle-Dot may be right for
you and ask about how you can get a One Month Free Trial
Offer of the #1 Prescribed Brand-Name Bioidentical Estrogen
Therapy.*†
Visit vivelledot.com to learn more and, while you’re there, sign
up for the By Your Side patient support service, a free reminder
program designed to help you stick with your treatment.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe
hot flashes; treat moderate to severe dryness, itching and burning
in or around the vagina; and help reduce your chances of getting
osteoporosis (thin weak bones).
My Journey. My Patch.
Please see Important Safety Information on back cover and
accompanying Full Prescribing Information for Vivelle-Dot.
*
Based on IMS Health®, National Prescription Audit Plus™, December 2009.
†
This means that the estrogen in Vivelle-Dot (estradiol) is identical to the hormone produced naturally by your body. This does not mean that it is safer or
more effective.
Choosing a Bioidentical ET That’s Right for You
If you’re considering a bioidentical ET, it’s important to discuss your options with your healthcare provider. Now that you know the
facts, here are some additional questions you may want to ask your doctor to help you in making your decision:
What are the most common FDA-approved bioidentical ETs?
Is there a difference between estrogens derived from plant versus animal sources?
How can I get the smallest dose of estrogen to relieve my symptoms?
I need a treatment that fits into my busy life, what are my options?
How long will it take for my therapy to start controlling my symptoms?
I’m also worried about my bone health. Is my ET also approved to prevent bone loss from menopause?
INDICATION
Vivelle-Dot® (estradiol transdermal system), is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe
dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat
certain conditions in which a young woman’s ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used
to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your
vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a
different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while
you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with
or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using
estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the
breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots;
currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
Please see accompanying Full Prescribing Information for Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Available by prescription only.
As You Journey Through Menopause,
Vivelle-Dot is By Your Side.
© 2010 Novartis
Printed in U.S.A.
My Journey. My Patch.
05/10
VVD-800160