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Raloxifene

(rah-lox-uh-feen)

Trade/other name(s): Evista, Keoxifene

Why would this drug be used?

Raloxifene was first used to prevent osteoporosis (bone loss). In bone cells, raloxifene acts like estrogen to prevent osteoporosis in women who have gone through menopause. It also helps to lower the fat in the blood (low density lipids, "bad cholesterol").

Raloxifene is now used in women who have gone through menopause and who are at high risk for developing breast cancer. It can reduce breast cancer risk in these women, although it cannot entirely prevent it.

How does this drug work?

Raloxifene is a hormone or hormone blocker (antagonist) that belongs to a group of drugs called selective estrogen receptor modulators (SERMs). Raloxifene blocks estrogen from binding to certain cells, such as those in the breast. The cancer cells that depend on estrogen to divide stop growing and die.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any medical conditions such as kidney disease, liver disease (including hepatitis), diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you smoke or have congestive heart failure, heart disease, irregular heartbeat, high blood pressure, or other conditions that may allow blood to clot; or if you have ever had blood clots, phlebitis, or a stroke. You may not be able to take raloxifene, since it can increase the risk of blood clots in the legs, arms, lungs, and brain (stroke).
  • If you have not completed menopause. This medicine is only for women who are menopausal.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may harm the fetus if the woman is taking it at the time of conception or during pregnancy. This drug was tested only in women who had gone through menopause. If you are not sure you've finished menopause, ask your doctor about what kinds of birth control can be used with this medicine.
  • If you are breast-feeding. It is not known whether this drug passes into breast milk. If it does, it could harm the baby.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Cholestyramine (Questran), colestipol (Colestid), and other such "resin" drugs can block raloxifene from being absorbed into the body.

Raloxifene should not be used with any medicine that contains estrogen, because it may interfere with raloxifene's effects. And, the safety of this combination has not been proven.

Medicines that keep blood from clotting, such as warfarin (Coumadin) can have increased effects while taking raloxifene. Your doctor will watch your blood tests. Your warfarin dose may need to be adjusted to avoid bleeding.

Check with your doctor, nurse, or pharmacist about other medicines, vitamins, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Raloxifene is a pill given once a day at about the same time each day. You can take it with or without food. The dose is the same for all patients. Take this drug exactly as directed by your doctor. If you do not understand the instructions, ask your doctor or nurse to explain them to you.

Keep the medicine in a tightly closed container away from heat and moisture and out of the reach of children and pets.

Precautions

It is important to keep taking this drug, even if you feel well. If you are bothered by side effects, talk to your doctor or nurse to find out if the problems are serious. Many side effects can be managed with help from your doctor.

Very rarely, this drug can cause blood clots. Sometimes they form in the arm or leg. Clots may cause heart attack, stroke, or blockage in the lungs. Call your doctor or nurse right away if you develop pain in your lower leg (calf), redness or swelling of your arm or leg, shortness of breath, chest pain, coughing up blood, sudden severe headache, confusion, dizziness, numbness, or trouble speaking or moving.

Talk to your doctor about stopping raloxifene at least 72 hours before you expect to be lying down or staying still for long periods of time, for example, to recover from surgery. Sitting or staying in one position for long periods may allow blood clots to form. You can start taking raloxifene again when you are up and walking. When you travel, get up and walk around a lot so you are not in the same position for a long time.

If you are pregnant or may become pregnant, you should not take this drug. It may cause birth defects or other serious problems for the baby. This drug is approved only for women who have completed menopause. Let your doctor know if you have any vaginal bleeding before or during treatment.

Tell your doctor or nurse if you get a rash.

Drug or blood clotting levels may need to be checked more often if you are also taking warfarin (Coumadin), a blood-thinning medicine.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • hot flashes
  • trouble sleeping

Less common

  • fluid weight gain
  • headaches
  • depression
  • fever
  • aches and pains in the joints
  • leg cramps
  • rash
  • flu-like symptoms
  • vaginal infections
  • urinary tract infections

Rare

  • blood clots in the legs, lungs, or brain (stroke)*
  • nausea
  • vomiting
  • heartburn
  • passing gas
  • death due to stroke*

*See the "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 1997 for preventing bone loss in women after menopause; approved in 2007 for breast cancer prevention.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 12/02/2009
Last Revised: 12/02/2009