FDA Approves Osteoporosis Drug to Cut Breast C...( Manufacturer calls Evista a valuable ...),Health

Manufacturer calls Evista a valuable tool, but critics say its heart risks outweigh benefits

FRIDAY, Sept. 14 (HealthDay News) -- Drug maker Eli Lilly and Company said Friday that its osteoporosis drug Evista has received U.S. approval for use in preventing breast cancer in certain groups of high-risk women.

The U.S. Food and Drug Administration approval covers postmenopausal women with osteoporosis and postmenopausal women at high risk of breast cancer, the company said in a prepared statement.

"For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns -- osteoporosis and invasive breast cancer," Gwen Krivi, vice president of Lilly Research Laboratories, said in a prepared statement. "Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction."

On July 24, the FDA's Oncologic Drugs Advisory Committee voted 8 to 6 to recommended approval of Evista (raloxifene) for postmenopausal women with osteoporosis, and voted 10 to 4 to recommended it for postmenopausal women at high risk for breast cancer.

The approval of Evista, which studies have shown can produce potentially dangerous side effects such as blood clots and stroke, would give women a valuable option in fighting breast cancer, one panel member said following the July vote.

"We've got a drug out there, tamoxifen, with its advantages and its possible flaws,'' David Harrington, chairman of the biostatistics department at Dana-Farber Cancer Institute in Boston, told Bloomberg news 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 agreed with the panel's recommendation.

"The reason that we are concerned and will continue to be concerned about it [Evista] is the hist
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