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The osteoporosis drug Evista was approved for the prevention of invasive breast cancer in high risk women by the U.S. Food and Drug Administration on Friday September 14, 2007. The drug made by Eli Lilly and Company is chemically raloxifene hydrochloride and is widely used in preventing and treating osteoporosis.
The new indications of Evista include reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer, the FDA said in its press release.
Breast cancer is one of the most common cancers in women, particularly in the developed countries. Over a million women are diagnosed worldwide every year, according to the International Agency for Research on Cancer (IARC) in Lyon, France.
There are more than 2.3 million women in the United States who have undergone treatment for breast cancer, which happens to be the second leading cause of cancer death in the country.
Although many drugs are available for preventing the risk of developing invasive breast cancer in post menopausal women, Evista is considered superior because of its ability to treat osteoporosis as well. According to the American Cancer Society, the chance of a woman having invasive breast cancer some time during her life is about 1 in 8.
The FDA approval for Evista to reduce the risk of invasive breast cancer is based on three clinical trials in 15,234 postmenopausal women comparing Evista to placebo, which demonstrated that Evista reduced the risk of invasive breast cancer by 44 to 71 percent.
However the FDA warned that Evista can cause serious side effects including blood clots in the legs and lungs, and death due to stroke.
"Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating. Evista should not be taken by premenopausal women and women who are or may become pregnant because it may cause harm to the unborn baby," the FDA added.
The adverse effects of raloxifene are highlighted in many studies. Another study called Raloxifene Use for The Heart (RUTH) trial involving more than 10,000 postmenopausal women assessed the effect of Evista on the heart if any.
Researchers found the drug did not set off adverse coronary events as compared to a placebo, but it did reduce the risk of invasive breast cancer by 44 percent.
But the worrying thing was that Evista appeared to increase the risk of a fatal stroke by 55 percent and the risk of blood clots by 44 percent in women who took the drug, a study published in July 2006 issue of New England Journal of Medicine pointed out.
Evista was approved by the FDA for preventing osteoporosis in postmenopausal women in 1997 and its indication was extended for he treatment of postmenopausal women with osteoporosis in 1999.
On July 24, 2007, FDA's Oncology Drugs Advisory Committee recommended that Evista be approved for preventing invasive breast cancer in high risk women. Steven Galson, M.D., M.P.H., director, FDA's Center for Drug Evaluation and Research said that Evista's approval added a new weapon in the fight against breast cancer.
"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," he added.
The National Cancer Institute estimates that at least 13.2 percent of the women born today will be diagnosed with breast cancer at some point in their lives.
About 178,480 women in the United States will be found to have invasive breast cancer in 2007. About 40,460 women will die from the disease this year, according to the latest data available from the American Cancer Society.
Consumers are advised to make informed choices before choosing to go with Evista because of its potentially lethal side effects. It must be noted that Evista does not completely prevent breast cancer.
As the FDA advises “Breast examinations and mammograms should be done before starting Evista and regularly thereafter.”
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