OBJECTIVES: This study evaluated characteristics of postmenopausal women (PMW) who initiated raloxifene (RLX) therapy before and after the approval of the invasive breast cancer (BC) risk reduction (IBCRR) indications. METHODS: PMW 50 years and older with at least one claim for RLX in 2005-2008 and continuous enrollment over the study period (Jan 2004-Dec 2008) were identified in a large national commercial and Medicare supplemental claims database. PMW on RLX were evaluated based on clinical and demographic variables such as age, provider specialty, fractures, bone mineral density (BMD) screening, Chronic Disease Score (CDS), family history of BC, and mammograms 12 months before and 12 months after the IBCRR indication approval. RESULTS: PMW who initiated RLX following the IBCRR approval versus before approval were less likely to be in the 50-54 age group compared to all other age groups (Adjusted Odds Ratio [AOR] = 1.594 [age 55-59], 1.812 [age 60-64], 1.667 [age 65-69], 1.782 [age 70+]). RLX initiators were more likely to have a lower CDS after the IBCRR approval vs. before approval (medium AOR = 0.795 [Confidence Interval (CI): 0.711, 0.889], high AOR = 0.71 [CI: 0.626, 0.805]). After the IBCRR approval, RLX initiators had a greater likelihood of having a code for family history of BC in the claims database (AOR = 1.761 [CI: 1.213, 2.556]) compared to RLX initiators before approval. PMW who initiated RLX after IBCRR approval did not differ significantly from those who initiated before approval with regard to mammograms, fractures, BMD screening, and provider specialty. CONCLUSIONS: PMW who initiated RLX after the IBCRR approval were more likely to be older, have a lower CDS, and have a family history of BC compared with RLX initiators before approval. Factors such as mammograms, fractures, BMD screening, and provider specialty did not differ before and after the IBCRR approval.