WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
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Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA
[see Warnings and Precautions ]
. Women with active or past history of venous thromboembolism should not take EVISTA
[see Contraindications].
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Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke
[see Warnings and Precautions and Clinical Studies].
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EVISTA SUMMARY
EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds.
Treatment and Prevention of Osteoporosis in Postmenopausal Women
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)].
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis
EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies ].
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer
EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies].
The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see Clinical Studies]. Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known.
High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.
After an assessment of the risk of developing breast cancer, the decision regarding therapy with EVISTA should be based upon an individual assessment of the benefits and risks.
EVISTA does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting EVISTA and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with EVISTA.
Important Limitations of Use for Breast Cancer Risk Reduction
- There are no data available regarding the effect of EVISTA on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of EVISTA.
- EVISTA is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
- EVISTA is not indicated for the reduction in the risk of noninvasive breast cancer.
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NEWS HIGHLIGHTS
Published Studies Related to Evista (Raloxifene)
Raloxifene adjunctive therapy for postmenopausal women suffering from chronic
schizophrenia: a randomized double-blind and placebo controlled trial. [2014]
raloxifene to risperidone versus risperidone with placebo... CONCLUSIONS: According to our findings, raloxifene as an adjunctive treatment to
What if the Women's Health Initiative had used transdermal estradiol and oral
progesterone instead? [2014]
The author considers hypothetical comparisons between oral conjugated equine
estrogens and transdermal estradiol and between oral medroxyprogesterone acetate
and oral micronized progesterone for their effects on four primary outcomes of
the Women's Health Initiative (WHI): cardiovascular disease risk, cerebrovascular
disease risk, venous thromboembolism risk, and breast cancer risk.
National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and
Raloxifene trial: advancing the science of recruitment and breast cancer risk
assessment in minority communities. [2013]
understanding of breast cancer risk assessment in minority communities... CONCLUSIONS: Recruitment strategies used in STAR for racial and ethnic minorities
Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. [2011.11]
CONCLUSIONS: Raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia who exhibit prominent negative symptoms appears to be useful in improving negative, positive, and general psychopathological symptoms. If more extensive and longer-term studies confirm and expand upon these positive results, the use of raloxifene could be recommended in postmenopausal patients with schizophrenia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01041092. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome. [2011.09]
OBJECTIVE: To compare the ovulation rate between raloxifene and clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS)...
Clinical Trials Related to Evista (Raloxifene)
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis [Completed]
To study the effect of long-term treatment with raloxifene, compared with placebo, on the
rate of new vertebral fractures in osteoporotic postmenopausal women with and without
existing vertebral fractures.
Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women [Completed]
The efficacy of raloxifene versus placebo was compared over a six-month period, as an
adjuvant treatment of the negative symptoms of schizophrenia in a group of 80
post-menopausal women. The aim of the study is to analyze whether raloxifene has an effect
on the positive and negative symptoms of schizophrenia, and on psychopathological symptoms
in general, and on social and neuropsychological functioning, and to study the influence of
genetic polymorphisms in treatment response.
Raloxifene for Women With Alzheimer's Disease [Completed]
This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of
women with Alzheimer's disease.
Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer [Active, not recruiting]
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy,
such as bicalutamide, may lessen the amount of androgens made by the body. Selective
estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to
stop the growth of prostate cancer.
PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating
patients with metastatic or hormone-refractory prostate cancer.
Long Term Effects of Raloxifene Treatment on Bone Quality [Completed]
This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of
long-term treatment with raloxifene on histomorphometry and bone quality in patients who
participated in the Continuing Outcomes Relevant to Evista Study.
Reports of Suspected Evista (Raloxifene) Side Effects
Fall (43),
HIP Fracture (26),
Pain (22),
Dizziness (22),
Breast Cancer (21),
Nausea (21),
Drug Ineffective (20),
Arthralgia (20),
Vomiting (19),
Femur Fracture (16), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 11 ratings/reviews, Evista has an overall score of 6.82. The effectiveness score is 6.55 and the side effect score is 7.45. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Evista review by 64 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | high blood levels of thrombisin |
| Dosage & duration: | | 60mg taken 1 per day for the period of 3 years and still taking |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | normal thrombosin level within 6 weeks |
| Side effects: | | none |
| Comments: | | 1 pill every morning |
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| | Evista review by 60 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | LOSS OF BONE DENSITY |
| Dosage & duration: | | 20MG taken everyday for the period of 5 YEARS |
| Other conditions: | | NONE |
| Other drugs taken: | | NONE | | |
Reported Results |
| Benefits: | | BONE DENSITY INCREASED. I HAD A BONE SCAN AND SHOWED ON THE BORDER LINE OF OSTEOPEROSIS, (?) WELL AFTER TAKING THIS DRUG, MY BONE MEASUREMENTS INCREASED. NO SIDE EFFECTS AND DEFIENTELY A GOOD MEDICATION FOR US BABY BOOMERS |
| Side effects: | | NONE I DID NOT HAVE ANY SIDE EFFECTS, ONLY THAT MAYBE IT WILL HELP TO PREVENT BREAST CANCER, I HAVE A STRONG FAMILY HISTORY, MOTHER, GRANDMOTHER, AUNTS, COUSINS, WHO HAVE DIED OF BREAST CANCER. SO THIS MEDICATION IS A GOOD THING FOR ME. |
| Comments: | | TOOK ONE TABLET A DAY, ALSO FOUND OUT IT HELPS TO PREVENT BREAST CANCER. I HAVE BEEN TAKING FOR OVER 5 YEARS NOW, I NEVER HAD A SIDE EFFECT, TAKE EVERYNIGHT WITH MY MEAL. NO ADVERSE EFFECTS. I WILL CONTINUE TO TAKE FOR THE REST OF MY LIFE. |
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| | Evista review by 51 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | osteopenia |
| Dosage & duration: | | 60 mg. taken once a day for the period of 2 weeks |
| Other conditions: | | hypothyroidism |
| Other drugs taken: | | levathyroxine, Lexapro, restasis | | |
Reported Results |
| Benefits: | | I didn't take the medicine long enough to get any benefits |
| Side effects: | | I started having side effects within days of taking it but didn't realize it thinking that I was dealing with other health issues. I started out having a very bad sore throat, hoarse voice and cough. Went to a RediClini and got on antibiotic. Also went to see a Dr. 2 days later and was given a prednisone pack because I had chest congestion and by that time I had laryngitis plus shortness of breath. I dealt with these symptoms for 2 weeks. Cough and wheezing got better and then I realized the connection between getting all of these symptoms and the side effects. Checked online and sure enough, all of them were listed so I called the Dr. and stopped the medicine. Shortness of breath is better and my voice is getting somewhat better. |
| Comments: | | None. |
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Page last updated: 2015-08-10
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