FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk

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

By Steven Reinberg
HealthDay Reporter
Friday, September 14, 2007; 12:00 AM

Copyright © 2007 ScoutNews, LLC. All rights reserved.

FRIDAY, Sept. 14 (HealthDay News) -- The U.S. Food and Drug Administration on Friday approved the use of the osteoporosis drug Evista for the prevention of invasive breast cancer in certain groups of high-risk women.

The approval covers postmenopausal women with osteoporosis and postmenopausal women at high risk of invasive breast cancer, according to the drug's maker, Eli Lilly and Company.

"Today's action provides an important new option for women at heightened risk of breast cancer," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "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."

"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.