January 8, 2003 |
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FDA Approves New Labeling and Provides New Advice to Postmenopausal
Women Who Use or Who Are Considering Using Estrogen and Estrogen With Progestin
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
- FDA will continue to engage the National Institutes of Health (which sponsored
the WHI) as well as manufacturers in pursuing research on questions involving
the safety and effectiveness of these products.
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FDA Press Release
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