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Evista

"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.

The committee voted 12-9 against continued marketing of the drug, citing"...

Evista

Evista Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Evista (raloxifene hydrochloride) is used to treat or prevent osteoporosis in postmenopausal women. Evista is also used to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis or who are otherwise at risk of invasive breast cancer. It is an estrogen agonist/antagonist. Common side effects include hot flashes, sweating, or leg cramps.

The recommended dosage is one 60 mg Evista tablet daily, taken any time of day without regard to meals. Evista may interact with cholestyramine, blood thinners, diazepam, diazoxide, birth control pills or hormone replacement therapy. Tell your doctor all medications you use. Evista must not be used during pregnancy because it may cause harm to a fetus. It is not known whether this drug passes into breast milk. Breast-feeding while using this medication is not recommended.

Our Evista (raloxifene hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Evista in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
  • pain or swelling in one or both legs;
  • swelling in your hands or feet;
  • fever, chills, sore throat, body aches, flu symptoms;
  • unusual vaginal bleeding;
  • breast pain, tenderness, or lump;
  • pain or burning when you urinate; or
  • severe pain in your lower back.

Less serious side effects may include:

  • hot flashes;
  • headache, dizziness, spinning sensation;
  • leg pain;
  • joint pain;
  • increased sweating;
  • nausea, vomiting, stomach pain; or
  • runny or stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Evista (Raloxifene) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Evista Overview - Patient Information: Side Effects

SIDE EFFECTS: Hot flashes, sweating, or leg cramps may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Raloxifene may infrequently cause stroke or serious blood clots to form in the legs, lungs, or eyes. Seek immediate medical attention if any of these unlikely but serious side effects occur: leg swelling/pain, trouble breathing, chest pain, sudden vision changes, severe headache, weakness on one side of the body, confusion.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Evista (Raloxifene)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Evista FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to EVISTA (raloxifene) in 3385 patients, including 2250 exposed for 1 year and 1972 for at least 3 years.

Osteoporosis Treatment Clinical Trial — The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months, and 5129 postmenopausal women were exposed to raloxifene (2557 received 60 mg/day, and 2572 received 120 mg/day). The incidence of all-cause mortality was similar between groups: 23 (0.9%) placebo, 13 (0.5%) EVISTA-treated (raloxifene 60 mg), and 28 (1.1%) raloxifene 120 mg women died. Therapy was discontinued due to an adverse reaction in 10.9% of EVISTA (raloxifene) -treated women and 8.8% of placebo-treated women.

Venous Thromboembolism: The most serious adverse reaction related to EVISTA (raloxifene) was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis). During an average of study-drug exposure of 2.6 years, VTE occurred in about 1 out of 100 patients treated with EVISTA (raloxifene) . Twenty-six EVISTA (raloxifene) -treated women had a VTE compared to 11 placebo-treated women, the hazard ratio was 2.4 (95% confidence interval, 1.2, 4.5), and the highest VTE risk was during the initial months of treatment.

Common adverse reactions considered to be related to EVISTA (raloxifene) therapy were hot flashes and leg cramps. Hot flashes occurred in about one in 10 patients on EVISTA (raloxifene) and were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter. Leg cramps occurred in about one in 14 patients on EVISTA (raloxifene) .

Placebo-Controlled Osteoporosis Prevention Clinical Trials — The safety of raloxifene has been assessed primarily in 12 Phase 2 and Phase 3 studies with placebo, estrogen, and estrogen-progestin therapy control groups. The duration of treatment ranged from 2 to 30 months, and 2036 women were exposed to raloxifene (371 patients received 10 to 50 mg/day, 828 received 60 mg/day, and 837 received from 120 to 600 mg/day).

Therapy was discontinued due to an adverse reaction in 11.4% of 581 EVISTA (raloxifene) -treated women and 12.2% of 584 placebo-treated women. Discontinuation rates due to hot flashes did not differ significantly between EVISTA (raloxifene) and placebo groups (1.7% and 2.2%, respectively).

Common adverse reactions considered to be drug-related were hot flashes and leg cramps. Hot flashes occurred in about one in four patients on EVISTA (raloxifene) versus about one in six on placebo. The first occurrence of hot flashes was most commonly reported during the first 6 months of treatment.

Table 1 lists adverse reactions occurring in either the osteoporosis treatment or in five prevention placebo- controlled clinical trials at a frequency ≥ 2.0% in either group and in more EVISTA (raloxifene) -treated women than in placebo- treated women. Adverse reactions are shown without attribution of causality. The majority of adverse reactions occurring during the studies were mild and generally did not require discontinuation of therapy.

Table 1: Adverse Reactions Occurring in Placebo-Controlled Osteoporosis Clinical Trials at a Frequency ≥ 2.0% and in more EVISTA (raloxifene) -Treated (60 mg Once Daily) Women than Placebo-Treated Womena

  Treatment Prevention
  EVISTA (raloxifene)
N=2557
%
Placebo
N=2576
%
EVISTA (raloxifene)
N=581
%
Placebo
N=584
%
Body as a Whole        
Infection A A 15.1 14.6
Flu Syndrome 13.5 11.4 14.6 13.5
Headache 9.2 8.5 A A
Leg Cramps 7.0 3.7 5.9 1.9
Chest Pain A A 4.0 3.6
Fever 3.9 3.8 3.1 2.6
Cardiovascular System        
Hot Flashes 9.7 6.4 24.6 18.3
Migraine A A 2.4 2.1
Syncope 2.3 2.1 B B
Varicose Vein 2.2 1.5 A A
Digestive System        
Nausea 8.3 7.8 8.8 8.6
Diarrhea 7.2 6.9 A A
Dyspepsia A A 5.9 5.8
Vomiting 4.8 4.3 3.4 3.3
Flatulence A A 3.1 2.4
Gastrointestinal Disorder A A 3.3 2.1
Gastroenteritis B B 2.6 2.1
Metabolic and Nutritional        
Weight Gain A A 8.8 6.8
Peripheral Edema 5.2 4.4 3.3 1.9
Musculoskeletal System        
Arthralgia 15.5 14.0 10.7 10.1
Myalgia A A 7.7 6.2
Arthritis A A 4.0 3.6
Tendon Disorder 3.6 3.1 A A
Nervous System        
Depression A A 6.4 6.0
Insomnia A A 5.5 4.3
Vertigo 4.1 3.7 A A
Neuralgia 2.4 1.9 B B
Hypesthesia 2.1 2.0 B B
Respiratory System        
Sinusitis 7.9 7.5 10.3 6.5
Rhinitis 10.2 10.1 A A
Bronchitis 9.5 8.6 A A
Pharyngitis 5.3 5.1 7.6 7.2
Cough Increased 9.3 9.2 6.0 5.7
Pneumonia A A 2.6 1.5
Laryngitis B B 2.2 1.4
Skin and Appendages        
Rash A A 5.5 3.8
Sweating 2.5 2.0 3.1 1.7
Special Senses        
Conjunctivitis 2.2 1.7 A A
Urogenital System        
Vaginitis A A 4.3 3.6
Urinary Tract Infection A A 4.0 3.9
Cystitis 4.6 4.5 3.3 3.1
Leukorrhea A A 3.3 1.7
Uterine Disorderb,c 3.3 2.3 A A
Endometrial Disorderb B B 3.1 1.9
Vaginal Hemorrhage 2.5 2.4 A A
Urinary Tract Disorder 2.5 2.1 A A
a A: Placebo incidence greater than or equal to EVISTA (raloxifene) incidence; B: Less than 2% incidence and more frequentwith EVISTA (raloxifene) .
b Includes only patients with an intact uterus: Prevention Trials: EVISTA (raloxifene) , n=354, Placebo, n=364; Treatment Trial:EVISTA (raloxifene) , n=1948, Placebo, n=1999.
c Actual terms most frequently referred to endometrial fluid.

Comparison of EVISTA (raloxifene) and Hormone Therapy — EVISTA (raloxifene) was compared with estrogen-progestin therapy in three clinical trials for prevention of osteoporosis. Table 2 shows adverse reactions occurring more frequently in one treatment group and at an incidence ≥ 2.0% in any group. Adverse reactions are shown without attribution of causality.

Table 2: Adverse Reactions Reported in the Clinical Trials for Osteoporosis Prevention with EVISTA (raloxifene) (60 mg Once Daily) and Continuous Combined or Cyclic Estrogen Plus Progestin (Hormone Therapy) at an Incidence ≥ 2.0% in any Treatment Groupa

  EVISTA (raloxifene)
(N=317)
%
Hormone Therapy
Continuous
Combinedc
(N=96) %
Hormone Therapy-Cyclicd
(N=219)
%
Urogenital      
Breast Pain 4.4 37.5 29.7
Vaginal Bleedingb 6.2 64.2 88.5
Digestive      
Flatulence 1.6 12.5 6.4
Cardiovascular      
Hot Flashes 28.7 3.1 5.9
Body as a Whole      
Infection 11.0 0 6.8
Abdominal Pain 6.6 10.4 18.7
Chest Pain 2.8 0 0.5
a These data are from both blinded and open-label studies.
b Includes only patients with an intact uterus: EVISTA (raloxifene) , n=290; Hormone Therapy-Continuous Combined, n=67;Hormone Therapy-Cyclic, n=217.
c Continuous Combined Hormone Therapy = 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesteroneacetate.
d Cyclic Hormone Therapy = 0.625 mg conjugated estrogens for 28 days with concomitant 5 mgmedroxyprogesterone acetate or 0.15 mg norgestrel on Days 1 through 14 or 17 through 28.

Breast Pain — Across all placebo-controlled trials, EVISTA (raloxifene) was indistinguishable from placebo with regard to frequency and severity of breast pain and tenderness. EVISTA (raloxifene) was associated with less breast pain and tenderness than reported by women receiving estrogens with or without added progestin.

Gynecologic Cancers— EVISTA (raloxifene) -treated and placebo-treated groups had similar incidences of endometrial cancer and ovarian cancer.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions reported since market introduction include — very rarely: retinal vein occlusion, stroke, and death associated with venous thromboembolism (VTE).

Read the entire FDA prescribing information for Evista (Raloxifene) »

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Evista - User Reviews

Evista User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Evista sorted by most helpful. Patient Discussions FAQs

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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