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Limited Use
[what does this mean?]
Generic drug name:
raloxifene
(ra LOX i feen)
Brand name(s):
EVISTA
GENERIC:
not available
FAMILY:
Selective Estrogen Receptor Modulators
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Raloxifene caused delayed or abnormal development and/or death in the young of animals exposed to it during pregnancy. If you are pregnant or thinking of becoming pregnant, you should not take raloxifene because of the potential danger to the fetus.
Breast-feeding Warning
It is likely that this drug, like many others, is excreted in human milk, and because of the potential for adverse effects in nursing infants, you should not take this drug while nursing.
Safety Warnings For This Drug [top]
FDA BLACK BOX WARNING
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
Things You Can Do to Prevent Falls
Falls, of course, will increase your chances of a fracture. Ask your doctor to review your continued need for and dose of any drug that causes you to be dizzy or drowsy. Check the list of drugs that can cause falls. Check your home for situations that can lead to falls such as areas that are not well lit or loose rugs on hardwood floors.
What You Can Do to Prevent Osteoporosis
Diet and Exercise
Many women are not at risk of developing hip or other types of fractures. Women who are thin or small-boned, particularly if they are Asian or white, and women who drink more than two alcoholic drinks per day are at higher risk of osteoporosis. Black women, heavy women, and women who get lots of exercise are at a lower risk. There are steps women can take to prevent osteoporosis; for instance, a lot of calcium in the diet from early adulthood and weight-bearing exercise such as jogging, walking, tennis, and bicycling. You should be receiving from 800 to 1,200 milligrams of calcium per day in your diet, depending on your age. Women who are postmenopausal require an average of 1,500 milligrams per day of calcium (see Calcium Content of Some Foods table in Osteoporosis). These two steps (diet and exercise) are enough to prevent osteoporosis in many adults.
Facts About This Drug [top]
Raloxifene (EVISTA) is approved for the prevention and treatment of osteoporosis in postmenopausal women. It is also approved to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. We list EVISTA as Limited Use for prevention and treatment of osteoporosis.
The drug belongs to the selective estrogen receptor modulators family, which acts like estrogen in bone and some other tissues but...
Raloxifene (EVISTA) is approved for the prevention and treatment of osteoporosis in postmenopausal women. It is also approved to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. We list EVISTA as Limited Use for prevention and treatment of osteoporosis.
The drug belongs to the selective estrogen receptor modulators family, which acts like estrogen in bone and some other tissues but antagonizes estrogen in reproductive tissues.[1] Whether this is important in terms of long-term adverse effects is unknown.
Raloxifene should not be used for the primary or secondary prevention of cardiovascular disease.[2],[3]
Raloxifene should be used with caution in patients with moderate to severe kidney problems.[2],[3]
Raloxifene should not be taken by women until after menopause. Safety and effectiveness have not been studied in men or children.
Adverse effects
Commonly reported adverse effects of raloxifene include hot flashes and leg cramps. Hot flashes are especially common in women near menopause, and raloxifene increases their incidence. Other adverse effects include flu symptoms, peripheral edema (swelling in the feet and legs), fluid in the endometrial cavity (inside the uterus) and high blood sugar.
The long-term effects of raloxifene, such as safety for more than two years or effects on the pituitary gland, are unknown.
Raloxifene and osteoporosis
Bisphosphonates are more effective than raloxifene in increasing bone mineral density, but there is no evidence from a head-to-head trial that either is superior in reducing the risk of fractures. Neither raloxifene nor bisphosphonates — except for alendronate, a bisphosphonate that reduces the risk of hip and wrist fractures in women with previous vertebral fractures — significantly reduces the risk of nonvertebral fractures compared with a placebo. Vertebral fracture is a spinal fracture that may or may not be symptomatic.
In a three-year treatment study in postmenopausal women, raloxifene increased bone mineral density of the lumbar spine and hip (the only two sites measured). However, of these two sites, raloxifene decreased the risk of fractures only in the spine. Indeed, the authors stated that, as in previous studies, “the effect of fracture reduction is not clearly related to the increase in bone mineral density.”[4] Of 12 kinds of nonspinal fractures tracked in this study, only ankle fractures were statistically reduced (1.1% versus 0.7%, a difference of only 0.4%). There was no reduction in the incidence of fractures of the hip, the site of most importance.[5],[6],[7]
Raloxifene’s strongest effect was on the risk of spinal fracture. For the group of patients without a history of spinal fractures, the incidence of new spinal fractures, as detected by X-ray, was reduced by 2.4% for a relative risk reduction of 55%. Spinal fractures occurred in 4.3% of placebo patients and 1.9% of raloxifene-treated patients. In the group of patients who had had a previous spinal fracture, there was a 6% reduction in spinal fractures as detected by X-ray: 20% in the placebo group and 14% in the raloxifene-treated group.[8]
The patients most in need of treatment were those who had had a painful spinal fracture (not just one found on X-ray). In this group, the difference between treated and untreated patients was only 1.3% (3.1% of placebo patients and 1.8% of raloxifene-treated patients had new painful spinal fractures over three years).[8]
Raloxifene and breast cancer
A clinical trial found that raloxifene was comparable to tamoxifen (NOLVADEX) in preventing breast cancer in postmenopausal women considered to be at a higher-than-average risk. However, in May 2006, the Medical Letter on Drugs and Therapeutics reviewed the limited data available and concluded the following:
It is not clear how the lower incidence of uterine cancer with raloxifene equates with the lower incidence of non-invasive breast cancer with tamoxifen. Longer studies to evaluate mortality are needed. No data are available on the efficacy or risk, if any, of switching from tamoxifen to raloxifene.
In May 2006, drug manufacturer Eli Lilly Canada Inc. issued a “Dear Health Care Professional” letter and a public communication regarding an association between raloxifene use and an increased risk of death due to stroke in postmenopausal women at increased risk of heart disease.[9],[10]
This is one of a limited number of drugs for which the FDA requires an FDA-approved Medication Guide to be dispensed when the prescription is filled. (You can see the Medication Guide for this drug by clicking here.)
In 2023, Neurogastroenterology and Motility published an article warning that postmenopausal women with osteoporosis who used raloxifene had an increased risk of gastroesophageal reflux disease (GERD).[11]
Regulatory actions surrounding raloxifene
2007: Raloxifene’s labeling was updated by the Food and Drug Administration (FDA) to include information that an increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at an increased risk of major coronary events.[12]
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
chlorotrianisene, cholestyramine, conjugated estrogens, DELESTROGEN, DES, diethylstilbestrol, esterified estrogens, ESTINYL, ESTRACE, ESTRADERM, estradiol, estradiol transdermal, estriol, estrogens, estrone, estropipate, ethinyl estradiol, MENEST, mestranol, NORETHINDRONE, NORINYL, OGEN, ORTHO-EST, ORTHO-NOVUM, polyestradiol, PREMARIN, LOCHOLEST, QUESTRAN, quinestrol
If you take these drugs your doctor may or may not change your doses: COUMADIN, diazepam, diazoxide, lidocaine, VALIUM, warfarin, XYLOCAINE.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if you continue to experience:
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed July 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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