FDA Panel OKs Osteoporosis Drug to Cut Breast Cancer Risk

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In the Raloxifene Use for The Heart (RUTH) trial -- which included more than 10,000 postmenopausal women -- researchers found that, compared with placebo, Evista had no significant effect on the risk of first-time coronary events.

At the same time, it reduced the risk of invasive breast cancer by 44 percent -- meaning about 1.2 fewer cases of cancer per 1,000 women treated with raloxifene per year.

However, while the study showed no significant difference in deaths from any cause, or total deaths from stroke, women in the raloxifene group did have a 55 percent increased risk of fatal stroke (0.7 excess fatal strokes per 1,000 women treated per year) and a 44 percent increased risk of blood clots (1.2 more cases per women treated per year), according to a report published last July in the New England Journal of Medicine.

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"We fail to understand why any woman in her right mind would want to expose herself to such risks," Brenner said. "If the drug is approved by the FDA, Eli Lilly & Co. [the maker of Evista] will heavily promote the drug, and many women will be made sick by in the interest of preventing breast cancer that will be in nobody's interest," she said.

Women should learn what this drug can and cannot do for them and make an informed choice, Brenner said. "Do not depend on the FDA to do that for you."

However, another expert backed the FDA panel's recommendation.

"The drug has been demonstrated to have benefit in preventing breast cancer in women at increased risk," said Dr. Len Lichtenfeld, the deputy chief medical officer at the American Cancer Society. "The drug should be approved. That would then give us two options, and Evista may have a better safety profile than tamoxifen," he said.

In the STAR (Study of Tamoxifen and Raloxifene) trial published last June, almost 20,000 postmenopausal women at increased risk for breast cancer took either tamoxifen or Evista daily for five years. Tamoxifen is the only drug approved for reducing breast cancer risk.

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