Evista (raloxifene hydrochloride), an osteoporosis prevention drug, has been approved to reduce breast cancer risk in some postmenopausal women, a recent U.S. Food and Drug Administration (FDA) press release says.
Until now only two drugs have been approved for breast cancer prevention. Tamoxifen is one of them. Now, it comes Evista as the second FDA approved breast cancer risk reducing drug.
What are the new uses for Evista?
Specifically, Evista has been approved for two types of women groups. Evista can be used for postmenopausal women with osteoporosis and for Postmenopausal women at high risk for invasive breast cancer, according to the FDA.
But, what is Evista?
Evista is a type of drugs called selective estrogen receptor modulators (SERMs). SERMS seem to reduce the risk of invasive breast cancer by blocking estrogen receptors in the breast. Most, but not all, breast cancers are sensitive to estrogen. However, keeping mind that not all breast cancer are sensitive to estrogen.
Why the FDA believes that Evista may aid Breast Cancer Patients?
The FDA analyzed data from three clinical trials in which Evista was tested against a placebo (no drug). Combining the three clinical trials more than 15500 postmenopausal women were enrolled. According to the FDA press release, those women receiving Evista decreased the risk of Breast Cancer Risk by a percentaht went from 44 to 71 percent.
Additionally, in a fourth clinical trial more than 19,000 women with a high risk of developing breast cancer were enrolled. The objective of this fourth test was to test the efficiency of Evista against the other breast cancer risk reducing approved drug Tamoxifen. The results of this clinical trial showed Evista equaled tamoxifen for breast cancer prevention.
What is the importance of Breast Cancer as a disease?
Among women in the U.S., breast cancer is the most common cancer and the second most common cause of cancer death (after lung cancer). Women in the U.S. have a 1 in 8 lifetime chance of developing invasive breast cancer and a 1 in 33 chance of breast cancer causing their death.[American Cancer Society].
Are there any risks associated with Evista?
The FDA press relase sends a warning about the risks involved in taking Evista. According to the press release Evista may cause death due to stroke and blood clots in the legs and lungs. Benefits should be weighed against risks on an individual basis. Premenopausal women and women who are or may become pregnant SHOULD NOT take Evista.
Women with current or prior blood clots in the legs, lungs, or eyes should not take Evista. Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating, according to the FDA press release.
Sources:
FDA Approves New Uses for Evista. FDA press release. URL: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01698.html
American Cancer Society. What are the statistics fro breast cancer? URL: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_breast_cancer_5.asp
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