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The estrogen and progestin dilemma: new advice, labeling guidelines.

Publication: FDA Consumer
Publication Date: 01-MAR-03
Format: Online - approximately 1190 words
Delivery: Immediate Online Access

Article Excerpt
The Food and Drug Administration is giving important new safety advice to postmenopausal women and their health-care providers concerning drug products that contain estrogen. The updated advice, which includes product label revisions, reflects the agency's review of data from the Women's by...

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...Health Initiative (WHI) study, sponsored the National Institutes of Health.

The landmark WHI study has raised concern about the risks associated with the use of estrogen and estrogen with progestin products, including increased risks for cardiovascular disease and breast cancer.

One arm of the WHI study found that after one year of treatment with estrogen with progestin, for every 10,000 women, there may be seven more cases of heart disease, eight more strokes, eight more instances of blood clots in the lungs, 13 more cases of blood clots in the limbs, and eight more cases of breast cancer. This part of the study was stopped in July 2002 after five years because the risks from taking the drug exceeded the benefits of reduced instances of colon cancer and bone fracture.

The WHI study included 16,000...

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