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During postmarketing surveillance, T4 elevations were reported for a few postmenopausal patients, which may be explained by increases in thyroid-binding globulin. These elevations were not accompanied by clinical hyperthyroidism. Variations in the karyopyknotic index on vaginal smears and various degrees of oestrogen effect on Pap smears have been infrequently seen in postmenopausal patients given tamoxifen. In the postmarketing experience with tamoxifen, infrequent cases of hyperlipidaemias have been reported. Periodic monitoring of plasma triglycerides and cholesterol may be indicated in patients with pre-existing hyperlipidaemias. Effects in Metastatic Breast Cancer Patients. As with other additive hormonal therapy (oestrogens and androgens), hypercalcaemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with tamoxifen. If hypercalcaemia does occur, appropriate measures should be taken and, if severe, tamoxifen should be discontinued. Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma. An increased incidence of uterine malignancies has been reported in association with tamoxifen treatment. The underlying mechanism is unknown, but may be related to the oestrogen-like effect of tamoxifen. Most uterine malignancies seen in association with tamoxifen are classified as adenocarcinoma of the endometrium. However, rare uterine sarcomas, including malignant mixed-mullerian tumours (MMMT), have also been reported. Uterine sarcoma is generally associated with a higher International Federation of Gynecology and Obstetrics (FIGO) stage (III/IV) at diagnosis, poorer prognosis, and shorter survival. Uterine sarcoma has been reported to occur more frequently among long-term users (?2 years) of tamoxifen than non-users. 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