"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"...
(raloxifene hydrochloride) Tablet for Oral Use
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
- Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA (see PRECAUTIONS). Women with active or past history of venous thromboembolism should not take EVISTA (see CONTRAINDICATIONS).
- 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 PRECAUTIONS, Clinical Studies).
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. The chemical structure is:
The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C28H27NO4S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.
EVISTA (raloxifene) is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.
What are the possible side effects of raloxifene (Evista)?
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...
What are the precautions when taking raloxifene (Evista)?
See also Warning section.
Before taking raloxifene, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active or past history of blood clots (e.g., deep venous thrombosis, pulmonary embolism, retinal vein thrombosis).
Lack of movement may increase the risk for blood clots. Your doctor will instruct you to stop taking this medication at least 3 days before surgery or during long periods of inactivity (e.g., bedrest). Do not start taking...
Last reviewed on RxList: 10/2/2007
This monograph has been modified to include the generic and brand name in many instances.
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