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Although the clinical relevance of these changes is unknown, some of these changes, especially vaginal adenosis, are similar to those seen in young women who were exposed to diethylstilbestrol in utero and who have a 1 in 1000 risk of developing clear-cell adenocarcinoma of the vagina or cervix. To date, in utero exposure to Tamoxifen has not been shown to cause vaginal adenosis, or clear-cell adenocarcinoma of the vagina or cervix, in young women. However, only a small number of young women have been exposed to Tamoxifen in utero , and a smaller number have been followed long enough (to age 15 to 20) to determine whether vaginal or cervical neoplasia could occur as a result of this exposure. There are no adequate and well-controlled trials of Tamoxifen in pregnant women. There have been a small number of reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths in pregnant women. If this drug is used during pregnancy, or the patient becomes pregnant while taking this drug, or within approximately two months after discontinuing therapy, the patient should be apprised of the potential risks to the fetus including the potential long-term risk of a DES-like syndrome. Reduction in Breast Cancer Incidence in High Risk Women: For sexually active women of child-bearing potential, Tamoxifen citrate therapy should be initiated during menstruation. In women with menstrual irregularity, a negative B-HCG immediately prior to the initiation of therapy is sufficient (See PRECAUTIONS-Information for Patients – Reduction in Breast Cancer Incidence in High Risk Women ). General: Decreases in platelet counts, usually to 50,000 to 100,000/mm 3 , infrequently lower, have been occasionally reported in patients taking Tamoxifen citrate for breast cancer, cheque drops 250 mcg oral steroids cheque drops. In patients with significant thrombocytopenia, rare hemorrhagic episodes have occurred, but it is uncertain if these episodes are due to Tamoxifen citrate therapy. Leukopenia has been observed, sometimes in association with anemia and/or thrombocytopenia. There have been rare reports of neutropenia and pancytopenia in patients receiving Tamoxifen citrate; this can sometimes be severe. In the NSABP P-1 trial, 6 women on Tamoxifen citrate and 2 on placebo experienced grade 3 to 4 drops in platelet counts (?50,000/mm 3 ). Information for Patients: Patients should be instructed to read the Medication Guide supplied as required by law when Tamoxifen citrate is dispensed. The complete text of the Medication Guide is reprinted at the end of this document. Reduction in Invasive Breast Cancer and DCIS in Women with DCIS: Women with DCIS treated with lumpectomy and radiation therapy who are considering Tamoxifen citrate to reduce the incidence of a second breast cancer event should assess the risks and benefits of therapy, since treatment with Tamoxifen citrate decreased the incidence of invasive breast cancer, but has not been shown to affect survival (See Table 1 in CLINICAL PHARMACOLOGY ). Reduction in Breast Cancer Incidence in High Risk Women: Women who are at high risk for breast cancer can consider taking Tamoxifen citrate therapy to reduce the incidence of breast cancer. Whether the benefits of treatment are considered to outweigh the risks depends on a woman’s personal health history and on how she weighs the benefits and risks. Tamoxifen citrate therapy to reduce the incidence of breast cancer may therefore not be appropriate for all women at high risk for breast cancer. Women who are considering Tamoxifen citrate therapy should consult their health care professional for an assessment of the potential benefits and risks prior to starting therapy for reduction in breast cancer incidence (See Table 3 in CLINICAL PHARMACOLOGY ). Women should understand that Tamoxifen citrate reduces the incidence of breast cancer, but may not eliminate risk. Tamoxifen citrate decreased the incidence of small estrogen receptor positive tumors, but did not alter the incidence of estrogen receptor negative tumors or larger tumors. In women with breast cancer who are at high risk of developing a second breast cancer, treatment with about 5 years of Tamoxifen citrate reduced the annual incidence rate of a second breast cancer by approximately 50%. Women who are pregnant or who plan to become pregnant should not take Tamoxifen citrate to reduce her risk of breast cancer. Effective nonhormonal contraception must be used by all premenopausal women taking Tamoxifen citrate and for approximately two months after discontinuing therapy if they are sexually active.
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