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In a 21-month carcinogenicity study in micethere was an increased incidence of ovarian tumors in female animals given 9 to 242 mg/kgwhich included benign and malignant tumors of granulosa/theca cell origin and benign tumors of epithelial cell originSystemic exposureAUCof raloxifene in this group was 0.3 to 34 times that in postmenopausal women administered a 60 mg doseThere was also an increased incidence of testicular interstitial cell tumors and prostatic adenomas and adenocarcinomas in male mice given 41 or 210 mg/kg4.7 or 24 times the AUC in humansand prostatic leiomyoblastoma in male mice given 210 mg/kg.

Other side effectsdrug interactionsdosageand pregnancy and breastfeeding safety information should be reviewed prior to taking this medication.

These results are consistent with data from human studies of radiocalcium kinetics and markers of bone metabolismand are consistent with the action of EVISTA as a skeletal antiresorptive agent.

Discontinuation from the study was required when excessive bone loss or multiple incident vertebral fractures occurredSuch discontinuation was statistically significantly more frequent in the placebo group3.7than in the EVISTA group1.1

A broken bone is a fractureThere are different types of fracturessuch ascompressedopenstressgreenstick.

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Raloxifene appears to act as an estrogen agonist in boneIt decreases bone resorption and bone turnoverincreases bone mineral densityBMDand decreases fracture incidencePreclinical data demonstrate that raloxifene is an estrogen antagonist in uterine and breast tissuesThese results are consistent with findings in clinical trialswhich suggest that EVISTA lacks estrogen-like effects on the uterus and breast tissue.

It is not known whether raloxifene passes into breast milk or if it could harm a nursing babyYou should not breast-feed while using this medicine.

Table 5EVISTA60 mg Once DailyRelated Increases in BMD for the Osteoporosis Treatment Study Expressed as Mean Percentage Increase vsPlacebo b,c.

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