To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Ortho-Prefest For Menopause Symptoms URL: http://www.pslgroup.com/dg/13EA8A.htm Doctor's Guide October 26, 1999
RARITAN, N.J. -- October 26, 1999 -- The U.S. Food and Drug Administration has approved Ortho-Prefest™ (17(beta)-estradiol/norgestimate) tablets, a new single tablet hormone replacement therapy (HRT) which combines 17(beta)-estradiol with the progestin, norgestimate. Ortho-Prefest is indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with the menopause, treatment of vulvar and vaginal atrophy and prevention of osteoporosis.
During clinical trials of postmenopausal women, Ortho-Prefest was proven safe and effective in reducing hot flashes and providing relief from vaginal atrophy.
For women using Ortho-Prefest, the most commonly reported side effects during one year of treatment were headache (23 percent) and breast pain (16 percent). Most women did not find these side effects serious enough to discontinue therapy. Other side effects reported during clinical trials include, but are not limited to back pain, fatigue, flu-like symptoms, abdominal pain, nausea, arthralgias (joint pain), dysmenorrhea (painful menstruation), vaginal bleeding, vaginitis, pharyngitis (inflammation of the throat), sinusitis and URIs (upper respiratory infections).
Hormone replacement therapy is not suitable for all women. Women should talk to their healthcare professional before starting HRT.
Estrogens should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active thrombophlebitis; or thromboembolic disorders. Estrogens have been reported to increase the risk of serious side effects including thromboembolic disorders, cardiovascular disease and endometrial carcinoma in postmenopausal women. Progestins taken with estrogen drugs significantly reduce but do not eliminate the risk of endometrial cancer that is associated with the use of estrogen.
Ortho-Prefest will be manufactured by Ortho-McNeil Pharmaceutical. The date of product availability has not yet been determined.
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