Evista

[Raloxifene]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Adverse Events in the Osteoporosis Treatment Clinical Trial

The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months and 5129 postmenopausal women were exposed to raloxifene (2557 received 60 mg/ day and 2572 received 120 mg/ day). The majority of adverse events occurring during the study were mild and generally did not require discontinuation of therapy.

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Therapy was discontinued due to an adverse event in 10.9% of EVISTA-treated women and 8.8% of placebo-treated women. Common adverse events considered to be related to EVISTA therapy were hot flashes and leg cramps. Hot flashes were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter.

Adverse Events in Placebo-Controlled Clinical Trials to Support the Osteoporosis Prevention Indication

The safety of raloxifene has been assessed primarily in 12 Phase 2 and Phase 3 studies with placebo, estrogen, and estrogen-progestin replacement therapy (HRT) control groups. The duration of treatment ranged from 2 to 30 months and 2036 women were exposed to raloxifene (371 patients received 10 to 50 mg/ day, 828 received 60 mg/ day, and 837 received from 120 to 600 mg/ day). The majority of adverse events occurring during clinical trials were mild and generally did not require discontinuation of therapy.

Therapy was discontinued due to an adverse event in 11.4% of 581 EVISTA-treated women and 12.2% of 584 placebo-treated women. Common adverse events considered to be drug-related were hot flashes and leg cramps (see Table 6). The first occurrence of hot flashes was most commonly reported during the first 6 months of treatment. Discontinuation rates due to hot flashes did not differ significantly between EVISTA and placebo groups (1.7% and 2.2%, respectively). Table 6 lists adverse events occurring in either the osteoporosis treatment or the prevention placebo-controlled clinical trial databases at a frequency 2.0% in either group and in more EVISTA-treated women than in placebo-treated women. Adverse events are shown without attribution of causality.

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