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November 21, 2009
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GENERIC NAME: raloxifene

BRAND NAME: Evista

DRUG CLASS AND MECHANISM: Estrogen is a hormone which among other actions, regulates the turnover (formation and destruction) of bone. Decreases in estrogen levels that are seen after menopause or after removal of the ovaries, lead to a loss of bone density and weakened bones, a condition called osteoporosis. Raloxifene decreases bone turnover and increases bone density although not to the same extent as estrogen itself. This makes bones stronger and prevents fractures in women with osteoporosis. Raloxifene is called a "selective estrogen receptor modulator" since it has effects like estrogen on some tissues but inhibits the effects of estrogen on other tissues. Raloxifene decreases low density lipoprotein (LDL or "bad") cholesterol in the blood; however, unlike estrogen, raloxifene does not increase high density lipoprotein (HDL or "good") cholesterol.

PRESCRIPTION: yes

GENERIC AVAILABLE: no

PREPARATIONS: Tablets, 60mg.

STORAGE: Tablets should be stored between 15° (59°F) and 30°C (86°F).

PRESCRIBED FOR: Raloxifene is prescribed for the prevention and treatment of osteoporosis in post-menopausal women.

DOSING: Raloxifene generally is prescribed once daily. It can be taken with or without meals. Persons with cirrhosis may need lower doses.

DRUG INTERACTIONS: Cholestyramine (Questran) reduces the absorption of raloxifene. Therefore, these two medications should be taken several hours apart. Raloxifene may slightly reduce the ability of blood to clot and thus increase the effects of medications that reduce clotting (blood thinners). Therefore, if raloxifene is given with blood thinners such as warfarin (Coumadin), the ability of blood to clot may need to be monitored more closely with frequent measurements of the prothrombin time of blood.

PREGNANCY: It is not known if raloxifene causes adverse fetal effects if taken during pregnancy although there is an increased risk of fetal abnormalities with the use of estrogens. Therefore, estrogens (and probably raloxifene) should not be taken during pregnancy.

NURSING MOTHERS: Raloxifene should not be used by nursing mothers.

SIDE EFFECTS: The most common side effects with raloxifene are hot flashes (seen in 1 of every four persons), sinusitis (1 in 10), weight gain (1 in 11), muscle pain (1 in 12), leg cramps (1 in 20), and ankle swelling (1 in 30).

Raloxifene increases the risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (blood clots in the lung). The greatest increase in risk occurs during the first 4 months of use. Patients taking raloxifene should avoid prolonged periods of restricted movement during travel when blood clots are more prone to occur.

Reference: FDA Prescribing Information


Last Editorial Review: 7/23/1998




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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raloxifene, Evista

What is osteoporosis?

Osteoporosis is a condition characterized by the loss of the normal density of bone, resulting in fragile bone. Osteoporosis leads to literally abnormally porous bone that is more compressible like a sponge, than dense like a brick. This disorder of the skeleton weakens the bone causing an increase in the risk for breaking bones (bone fracture).

Normal bone is composed of protein, collagen, and calcium all of which give bone its strength. Bones that are affected by osteoporosis can break (fracture) with relatively minor injury that normally would not cause a bone fracture. The fracture can be either in the form of cracking (as in a hip fracture), or collapsing (as in a compression fracture of the vertebrae of the spine). The spine, hips, and wrists are common areas of bone fractures from osteoporosis, although osteoporosis-related fractures can also occur in almost any skeletal bone.

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