Menopausal
Hormone Therapy
A nationwide
campaign led by the Food and Drug Administration and other
Department of Health and Human Services agencies seeks to
provide better health information to women about the use of
hormones to treat symptoms of menopause.
FDA Commissioner
Mark B. McClellan, M.D., Ph.D., and several members of Congress
announced the menopausal hormone therapy campaign in September
2003. The collaborative campaign is aimed at raising awareness
about recent findings on the risks and benefits of menopausal
hormone therapy and making sure that women have the latest
information about the safe use of FDA-approved drugs to relieve
menopausal symptoms.
"Postmenopausal
hormone therapy is a major, personal decision
for women, and they should be armed with the latest key facts
and useful tools to make the best decision for their needs,"
says McClellan.
In the
spring of 2003, Congress directed the FDA to develop and execute
this important information campaign through partnerships with
organizations nationwide. More than 10 million women use menopausal
hormone therapies (estrogen or estrogen with progestin) for
relief from symptoms of menopause.
"The
choice of whether or not to undergo hormone therapy is a decision
that will affect all women at some point in our lives,"
says Rep. Rosa DeLauro, D-Conn. "That is why it is critical
that women have the information they need so they know their
options and can make the right decision for them."
The campaign
is designed to clarify the recent information from studies,
including the Women's Health Initiative (WHI) study sponsored
by the National Institutes of Health (NIH). One arm of the
WHI was halted in July 2002 due to concerns about increased
risks of some health problems. The study has led to new understanding
of the impact of long-term hormone therapy on women's health.
In January
2003, based on the findings of the WHI study, the FDA advised
women and health care professionals that menopausal hormone
therapy is associated with an increased risk of heart disease,
heart attacks, strokes, and breast cancer. The warning emphasized
that these products are not approved for heart disease prevention.
Because
there are few proven alternatives for the relief of hot flashes
and vulvar and vaginal atrophy (burning, itching and dryness
in and around the vagina), menopausal hormone therapies have
an important role in women's health. "It is very important
that women realize that this beneficial therapy also carries
significant risks," says McClellan. "Our recommendation
is that if you choose to use hormone therapy for hot flashes
or vaginal dryness, or if you prefer it to other treatments
to prevent thin bones, take the lowest dose for the least
duration required to provide relief."
The FDA
has modified the product labeling of menopausal hormone
therapies to clarify that these drugs should be used
only when the benefits clearly outweigh risks. As new information
becomes available that affects women's health, the FDA will
be carefully evaluating that information to ensure that FDA-approved
products remain safe and effective.
Working
in collaboration with the NIH and other HHS agencies, the
FDA has developed science-based materials on its latest guidance
on menopausal hormone therapies. The FDA is working closely
with a wide range of cosponsoring organizations, including
women's and community-based health and advocacy organizations,
to get this information out to women and health care providers.
"This campaign is a great example of the good that can
be achieved by nonprofits, industry and governmental agencies
working together to leverage resources to improve public health
and save taxpayer dollars," says Rep. Henry Bonilla,
R-Texas.
The main
tools of the campaign are a menopause and hormone-therapy
fact sheet and a purse-size guide that gives women questions
they can discuss with their health professionals. These materials
are available in both English and Spanish from the National
Women's Health Information Center at www.4woman.gov.
source:
http://www.fda.gov/fdac/
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