New drug cleared for osteoporosis in women.The FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. has cleared for marketing a new drug for the prevention of osteoporosis in postmenopausal post·men·o·paus·al
Of or occurring in the time following menopause.
postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr women. Called Evista, the drug is the first in a class of new drugs called selective estrogen receptor modulators (SERMs) to be used for this purpose.
"Millions of postmenopausal women at risk for osteoporosis will soon have a new option for stopping bone loss and preserving their strength," says Dr. August M. Watanabe, president of Lilly Research Laboratories Lilly Research Laboratories is the organizational name of the global pharmaceutical research and development organization of Eli Lilly and Company, one of the world's largest pharmaceutical corporations. , a division of Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. , the drug's manufacturer. Lilly expects the drug to be available in pharmacies by now.
Osteoporosis, which affects more than 28 million Americans, most of them women, is just one result of menopause. As a woman's ovaries stop producing estrogen, her bones become increasingly fragile and can easily break. Already more than 12,000 women in 28 countries have participated in 50 clinical studies on Evista.
"Clinical studies show that Evista acts like estrogen in the skeletal system and stops the loss of bone that occurs after menopause," says investigator Robert Lindsay, M.D., Ph.D., chief of internal medicine at Helen Hayes Hospital in New York. "The preservation of healthy bone is critical in preventing the onset of osteoporosis and protecting a woman during her postmenopausal years."
Evista was not shown in clinical trials to increase the risk of endometrial endometrial /en·do·me·tri·al/ (en?do-me´tre-il) pertaining to the endometrium.
n relating to the end-ometrium or cavity of the uterus. or breast cancer. However, as with most drugs, Evista is associated with some side effects, the majority of which were reported as mild. The most serious side effect associated with Evista was an increase in venous thromboembolic thromboembolic
pertaining to or emanating from thromboembolism.
see thromboembolic colic. events, but this was rare. The most common side effect observed was a higher rate of "hot flashes" among women who took the drug during clinical studies, compared to those who took a placebo. Women taking Evista also reported a higher rate of leg cramps than women taking placebos; nevertheless, the cramps did not cause them to stop taking Evista.
The occurrence of adverse uterine tissue effects and vaginal bleeding were no different between women taking Evista and women taking placebos in clinical trials. In contrast, women taking hormone-replacement therapy (HRT HRT
hormone replacement therapy
Hormone replacement therapy (HRT)
Also called estrogen replacement therapy, this controversial treatment is used to relieve the discomforts of menopause. ) had an increased incidence of spotting and bleeding. Women taking Evista also reported no differences regarding breast pain between themselves and those who took placebos, but women taking HRT reported increased incidence of breast pain. Finally, Evista produced significant reductions in LDL LDL - ["LDL: A Logic-Based Data-Language", S. Tsur et al, Proc VLDB 1986, Kyoto Japan, Aug 1986, pp.33-41]. (low-density lipoprotein, or "bad") cholesterol and total cholesterol, and did not change triglyceride levels.
Evista, under the generic name of raloxifene hydrochloride, will be available as a preventive for postmenopausal American women in 60 mg tablets. Its manufacturer has already submitted applications, to market the drug in more than 30 countries around the world.