WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS

Serious and life-threatening events from the use of SOLTAMOX include uterine malignancies, stroke, and pulmonary embolism [see Warnings and Precautions (5.1, 5.2)]. Fatal cases of each type of event have occurred.

Incidence rates per 1000 women-years for these events were estimated from the National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1 trial in women at high risk for breast cancer [see Clinical Studies (14.4)]:

• Endometrial adenocarcinoma: 2.20 for tamoxifen vs. 0.71 for placebo
• Uterine sarcoma: 0.17 for tamoxifen vs. 0.04 for placebo
• Stroke: 1.43 for tamoxifen vs. 1.00 for placebo.
• Pulmonary embolism: 0.75 for tamoxifen versus 0.25 for placebo.

Discuss the potential benefits of tamoxifen versus the potential risks of these serious events with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) considering tamoxifen to reduce the risk of developing breast cancer [see Warnings and Precautions (5)]. For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks.