FDA Panel OKs Osteoporosis Drug to Cut Breast Cancer Risk

By Steven Reinberg
HealthDay Reporter
Tuesday, July 24, 2007; 12:00 AM

TUESDAY, July 24 (HealthDay News) -- Despite concerns over cardiovascular side effects, a U.S. Food and Drug Administration panel on Tuesday recommended the osteoporosis drug Evista (raloxifene) for use in preventing breast cancer in certain high-risk groups of older women.

In a vote of 8 to 6, the FDA's Oncologic Drugs Advisory Committee recommended approval of the drug for postmenopausal women with osteoporosis, and, in a 10 to 4 vote, it also recommended the drug for postmenopausal women at high risk for breast cancer.

While the FDA usually follows the recommendations of its expert panels, it is not obligated to do so.

Evista's approval would give women a valuable option in fighting breast cancer, one expert said.

"We've got a drug out there, tamoxifen, with its advantages and its possible flaws,'' panel member David Harrington, chairman of the biostatistics department at Dana-Farber Cancer Institute in Boston, toldBloombergnews service. "Women at high risk for breast cancer, it would be very nice to have a second option for them," he said.

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

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

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," she said.

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 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.

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