Background: Tamoxifen is generally considered a safe drug for Indian womenwith breast cancer. Indian women seem to tolerate tamoxifen therapy better than western women, but thereare no data regarding safety and local adverse effect profiles in typical Indian populations. Methods and Results:A total of 3,000 case records of patients who had received tamoxifen daily for any period of time, betweenJanuary 1988 and December 2007, were identified for study. Hot flashes were reported by 800 (26%), mildvaginal dryness by 450 (15%) and vaginal discharge by 300 (10%), with vaginal bleeding experienced by 40(1.3%) patients. A total of 1,100 (36.6%) asymptomatic patients had a thickened endometrium(defined as >8mmin thickness) on ultrasonography. Endometrial curettage was performed in all of these. None of the patientsdeveloped endometrial carcinoma. Fatty infiltration of liver was found in 1,440 (48%) patients with a meantime interval for development of 7 months (range 6-30 months). Conclusions: Fatty infiltration of liver is foundin almost half of the Eastern Indian women who receive tamoxifen. Increased endometrial thickness, whichremains asymptomatic, was documented in more than one third of patients on ultrasound examination. Tamoxifenseems to have a negligible potential for causation of uterine malignancies in eastern Indian women. Rates ofhysterectomies in Indian patients on tamoxifen are substantially lower than those of western patients on tamoxifen.
)