Tamoxifen use in Indian women--adverse effects revisited.

BACKGROUND Tamoxifen is generally considered a safe drug for Indian women with breast cancer. Indian women seem to tolerate tamoxifen therapy better than western women, but there are 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, between January 1988 and December 2007, were identified for study. Hot flashes were reported by 800 (26%), mild vaginal 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 >8mm in thickness) on ultrasonography. Endometrial curettage was performed in all of these. None of the patients developed endometrial carcinoma. Fatty infiltration of liver was found in 1,440 (48%) patients with a mean time interval for development of 7 months (range 6-30 months). CONCLUSIONS Fatty infiltration of liver is found in almost half of the Eastern Indian women who receive tamoxifen. Increased endometrial thickness, which remains asymptomatic, was documented in more than one third of patients on ultrasound examination. Tamoxifen seems to have a negligible potential for causation of uterine malignancies in eastern Indian women. Rates of hysterectomies in Indian patients on tamoxifen are substantially lower than those of western patients on tamoxifen.