New Indication Approved for Tamoxifen
Dateline: 10/29/98
FDA Approval of Tamoxifen Announced
Zeneca Pharmaceuticals announced today that the FDA has approved a new indication for the use of its breast cancer drug Nolvadex (tamoxifen citrate). According to a press release issued by the Food and Drug Administration (FDA) the labeled indication is for "the reduction in incidence of breast cancer in women at high risk for developing the disease." This marks the first time a drug has been approved as a measure to reduce the incidence of breast cancer in high risk women.
Tamoxifen has been used for more than 20 years and this is a new indication for its use that resulted from a recent study of the drug that was conducted by the National Cancer Institute (NCI). Participants included women who were judged to be at increased risk of breast cancer. The study showed that tamoxifen reduced the chance of getting breast cancer by 44 percent. The data also revealed that tamoxifen treatment did not completely eliminate breast cancer risk. The long term effects of tamoxifen are not known.
Tamoxifen also received approval for the reduction of colateral breast cancer in women who currently have one affected breast. Nolvadex is supported as an adjuvant, five-year, therapy for breast cancer patients.
Robert C. Black, Zeneca's president said in today's news release,"For the millions of women who are at high risk of developing breast cancer there is now something they can do to reduce their risk of developing the disease. It's a new option--a choice--that many women will now have available to them as they discuss their breast health with their doctors." Mr. Black also stressed that breast self-exam and mammography are still important tools for early detection of breast cancer.
Risk Factors
The FDA strongly urges that Nolvedex should be prescribed only for women at high risk for breast cancer and only after careful medical evaluation of an individual woman's risk factors. Risk factors include age, personal health history and family history of breast cancer -- factors that are outlined in the approved labeling.
The National Cancer Institute study use a computerized model, called the "Gail model," for determining a woman's risk of breast caner. The manufacturer of this model, recognizing that not all health care providers have access to this computer model will provide materials to health care providers to calculate the risk. Women who score 1.67 or higher should discuss the use of tamoxifen with her physician.
The FDA has also required that labeling provide information for doctors to help them identify women who should receive this drug. As an example, risk factors that would result in an increased risk of breast cancer in a woman age 50 or older include that all of the following risk factors be present:
- Family history of breast cancer (at least two direct line relatives with breast cancer)
- Personal health history (Presence of atypical hyperplasia on breast biopsy)
- Had first child at age 30 or older started menstruating at age 11 or younger.
Side Effects
In today's FDA press release Dr. Michael A. Friedman, Acting FDA Commissioner said "As with all drugs, there are risks associated with use. As valuable as tamoxifen is to some patients, FDA strongly advises women and their doctors to carefully weigh the benefits and risks of tamoxifen before patients use the drug."
The most common side effects of tamoxifen which is a nonsteroidal anti estrogen are hot flashes and vaginal discharge. However, the FDA stresses that caution must be used in prescribing tamoxifen as a preventive measure against breast cancer due to its potentially serious side effects which include endometrial cancer (cancer of the lining of the uterus), deep vein thrombosis (blood clots in major veins), and pulmonary embolism (serious blood clots in the lungs).
Pregnant women or women who require concomitant courmarin-type anticoagulant therapy or who have a history of deep vein thrombosis or pulmonary embolus should not take tamoxifen for breast cancer reduction.
Tamoxifen Related Net Links
Tamoxifen May
Save 20,000 Lives Annually
From the Doctor's Guide
Tamoxifen
as Treatment for Breast Cancer
From the Susan G. Komen Foundation
Tamoxifen
Warning: Increased Risk of Cancer of the Uterus
From OncoLink and the University of Pennsylvania Cancer
Center
Tamoxifen
Survey Report
From the Breast Cancer Action Center of Nova Scotia
Breast Cancer
Facts
From your About.com Guide
More About Breast Cancer
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