WASHINGTON Apr 17, 2006 (AP) -
Raloxifene, the newer drug already is used to help prevent and treat thinning of the bones (osteoporosis) only in postmenopausal women.
It works like an estrogen to stop the bone loss that can develop in women after menopause, but it does not increase the bone density as much as daily 0.625 mg doses of conjugated estrogens. Raloxifene will not treat hot flashes of menopause and may cause hot flashes to occur. Also, raloxifene does not stimulate the breast or uterus as estrogen does.
Raloxifene lowers the blood concentrations of total and low-density lipoprotein (LDL) cholesterol, the bad cholesterols, but it does not increase concentrations of high-density lipoprotein (HDL) cholesterol, the good cholesterol, in your blood.
This medicine is available only with your doctor's prescription, in the following dosage form(s): Oral Tablets (U.S.)
Raloxifene sells under the brand name Evista. Manufacturer Eli Lilly & Co.
EVISTAŽ (raloxifene hydrochloride) is a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds.
EVISTA 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, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.
Tamoxifen has been the only drug approved to reduce the chances of breast cancer striking high-risk women.
Estrogen can fuel certain breast cancers, making tamoxifen a longtime top choice both to prevent the disease's return in women with estrogen-sensitive tumors and to reduce the odds of it striking high-risk women in the first place.
But tamoxifen causes some rare but serious side effects: It acts like an estrogen in the uterus and bloodstream, thus increasing users' risk of getting uterine cancer or a life-threatening blood clot.
Raloxifene is a close chemical relative, in the same drug family known as "selective estrogen response modulators," and earlier research suggested that it might help breast cancer, too.
The NCI launched the $88 million study to compare the two.
Taking either tamoxifen or raloxifene every day cut in half women's chances of developing invasive breast cancer, NCI announced Monday.
The initial results show:
Raloxifene causes the same side effects, but not as many:
Raloxifene users had 36 percent fewer uterine cancers and 29 percent fewer blood clots,
RARE (Stop taking this medicine and get emergency help immediately)
headache or migraine headache;
loss of or change in speech, coordination, or vision;
pain or numbness in chest, arm, or leg ;
shortness of breath (unexplained)
MORE COMMON (Check with your doctor as soon as possible)
Bloody or cloudy urine;
difficult, burning, or painful urination;
frequent urge to urinate;
infection, including body aches or pain, congestion in throat, cough, dryness or soreness of throat, and loss of voice;
runny nose ;
leg cramping; skin rash ;
swelling of hands, ankles, or feet; vaginal itching
Abdominal pain (severe);
aching body pains;
congestion in lungs;
decreased vision or other changes in vision;
difficulty in breathing;
loss of appetite;
trouble in swallowing;
MORE COMMON (Other side effects may occur that usually do not need medical attention)
Hot flashes, including sudden sweating and feelings of warmth (especially common during the first 6 months of treatment);
increased white vaginal discharge;
joint or muscle pain;
problems of stomach or intestines, including passing of gas, upset stomach, or vomiting;