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Evista OK for Breast Cancer Prevention

FDA Approves [DEF]Osteoporosis[/DEF] Drug Evista for Breast Cancer Prevention in Certain [DEF]Postmenopausal[/DEF] Women

Sept. 14, 2007 -- The FDA today approved the osteoporosis drug Evista to reduce breast cancer risk in some postmenopausal women.

Specifically, the FDA approved Evista to lower the risk of invasive breast cancer (the most common form of breast cancer) in two groups of women:

  • Postmenopausal women with osteoporosis
  • Postmenopausal women at high risk for invasive breast cancer

Evista is only the second drug approved to reduce breast cancer risk (tamoxifen was the first).

In the U.S., breast cancer is the No. 2 cause of women's cancer deaths (lung cancer is first). Breast cancer accounts for 26% of all cancers among U.S. women.

"Today's action provides an important new option for women at heightened risk of breast cancer," says Steven Galson, MD, MPH, in an FDA news release.

But Galson -- who directs the FDA's Center for Drug Evaluation and Research -- cautions that Evista may not be right for all postmenopausal women.

Weigh Risks, Benefits
"Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman. Women should talk with their health care provider about whether the drug is right for them," says Galson.

The FDA notes that Evista can cause serious side effects including blood clots in the legs and lungs and death due to stroke. Women with current or previous blood clots in the legs, lungs, or eyes shouldn't take Evista.

Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating, according to the FDA.

Evista shouldn't be taken by premenopausal women and women who are pregnant or may become pregnant because the drug may harm the fetus. Evista also shouldn't be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.

Evista doesn't completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter.

About Evista
Evista belongs to a class of drugs of called selective estrogen receptor modulators (SERMs).

SERMS may reduce the risk of invasive breast cancer by blocking estrogen receptors in the breast, according to the FDA. Most, but not all, breast cancers are sensitive to estrogen.

Today's FDA action is in line with an FDA advisory committee's recommendation made in late July. The FDA often follows its advisory committees' recommendations, but it isn't required to do so.

The FDA first approved Evista in 1997 to prevent osteoporosis in postmenopausal women. Two years later, the FDA approved Evista for osteoporosis treatment in postmenopausal women.

Today's FDA action is in line with an FDA advisory committee's recommendation made in late July. The FDA often follows its advisory committees' recommendations, but it isn't required to do so.

Evista for Breast Cancer Prevention
The FDA approved Evista's new uses for breast cancer prevention based on four clinical trials conducted over the last decade.

Three of the trials compared Evista with a pill containing no medicine (placebo) in more than 15,000 postmenopausal women. Those trials show that Evista "reduces the risk of invasive breast cancer by 44% to 71%," states the FDA.

The fourth clinical trial, which included more than 19,000 postmenopausal women at high risk for developing breast cancer, compared Evista to tamoxifen. In that trial, Evista equaled tamoxifen for breast cancer prevention.

Evista is made by Eli Lilly and Company.
 

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