FDA Approves New Labeling and Provides New Advice to Postmenopausal Women Who Use or Who Are Considering Using Estrogen and Estrogen With Progestin
Adapted by Tracee Cornforth
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.
Adapted from the FDA
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