[Safety profile of raloxifene]

Selective estrogen receptor modulators (SERMs) are a diverse group of non-steroidal (non hormonal) compounds developed to offer the postmenopausal women many of the advantages of estrogen therapy (ET) while avoiding undesired effects on reproductive and other tissues. Tamoxifen and toremifene, first generation SERMs are used for the adjuvant treatment of breast cancer worldwide, but their stimulatory effect on the uterus prevents their widespread use in other indications. A second generation SERM, raloxifene hydrochloride, a benzothiophene SERM is fully safe for the uterus and significantly reduces the risk of vertebral fractures in postmenopausal women with osteoporosis. The safety and efficacy of raloxifene in postmenopausal women have been studied extensively in more than 40,000 women over 50 clinical trials in 30 countries. The majority of the trials have been large double-blind placebo-controlled trials, including Asia and Japan. Raloxifene is well tolerated, with the only common side effects significantly higher than placebo being hot flushes and minor leg cramps. Venous thromboembolism was the only adverse events of clinical significance but rare associated with raloxifene in Caucasian women, but was not observed so far in Asian countries.