FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk

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However, not everyone agreed with the panel's recommendation.

"The reason that we are concerned and will continue to be concerned about it [Evista] is the history of every drug that's ever been used to 'prevent breast cancer,' " Barbara Brenner, executive director of Breast Cancer Action, told HealthDay.

Brenner noted that even women who do take these drugs can get breast cancer.

"In addition, the number of women who are going to be exposed to a drug with very serious and potentially fatal side effects in the interest of reducing very small numbers of breast cancer is very frightening to us," Brenner said. "We would like to see this disease prevented but not at the risk to women's health."

While Evista has been shown to reduce the risk of breast cancer among postmenopausal women with osteoporosis, and postmenopausal women at high risk for breast cancer, it also increases their risks for blood clots and stroke.

In the Raloxifene Use for The Heart (RUTH) trial -- which included more than 10,000 postmenopausal women -- researchers found that, compared with a 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 in July 2006 in the New England Journal of Medicine.

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, Dr. Len Lichtenfeld, the deputy chief medical officer at the American Cancer Society, backed the FDA panel's July recommendation.