Progesterone
Resource Center
FDA
Approves New Labeling and Provides New
Advice to Postmenopausal Women Who Use
or Who Are Considering Using Estrogen
and Estrogen With Progestin
article syndicated from FDA
FDA's
Actions
-
FDA
has carefully reviewed data from
the Women's Health Initiative (WHI)
study to ensure that the labels of
Prempro and similar estrogen, and
estrogen with progestin, products
are accurate.
-
FDA
has revised the labeling of Prempro,
Premphase and Premarin for patients
and physicians to reflect the WHI
study's findings of increased risk
from these products.
-
For
two uses, FDA has revised the professional
and consumer labels to include consideration
of alternative therapies that may
provide benefits to postmenopausal
women.
-
When
these products are being prescribed
solely for symptoms of vulvar and
vaginal atrophy, the new label recommends
that topical products be considered.
-
When
these products are only used for
osteoporosis prevention, the new
label specifies that the risks for
osteoporosis must outweigh the risk
of estrogen or estrogen with progestin.
-
FDA
is asking all manufacturers to update
their labeling with the results of
the WHI, because all estrogen and
progestin products are believed to
have similar risks
-
FDA
will soon revise its formal guidances
for industry in two related areas:
labeling for all estrogen and estrogen
with progestin products for postmenopausal
women, and recommendations for conducting
clinical trials to develop new products
for postmenopausal women.
FDA's
Advice to Women
-
Estrogens
provide valuable therapy for many
women, but carry serious risks, and
therefore postmenopausal women who
use or are considering using estrogen
or estrogen with progestin treatments
should discuss with their physicians
whether the benefits outweigh the
risks.
-
For
hot flashes and symptoms of vulvar
and vaginal atrophy, these products
are the most effective approved therapies.
-
Estrogens
and progestins should be used at
the lowest doses for the shortest
duration to reach treatment goals,
although it is not known at what
dose there may be less risk of serious
side effects.
Background
on the WHI Study
-
The
WHI study included 16,000 women ages
50 to 79, with a uterus, taking Prempro
or a placebo.
-
In
July 2002, one "arm" of
the study was halted because it showed
that the overall health risk (especially
of cardiovascular disease and breast
cancer) from taking estrogens with
progestin was greater than the benefits
of lowering the risk of colon cancer
and bone fractures.
-
The
study showed that, for every 10,000
women taking estrogen with progestin
for one year, there may be seven
more cases of heart disease, eight
more strokes, eight more blood clots
to the lungs (13 more in the limbs)
and eight more cases of breast cancer
- while there may be six fewer cases
of colon cancer and five fewer hip
fractures.
More
Research Needed
article
syndicated from U.S.
Food and Drug Administration:
http://www.fda.gov/oc/factsheets/WHI.html
FDA Fact Sheet: January 8, 2003
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