Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ortho-McNeil Pharmaceutical, R.W. Johnson
Approval Status: October 22, 1999
Treatment Area: Treatment of vasomotor symptoms assoc. w/menopause; vulvar, vaginal atrophy; prevention of osteoporosis
ORTHO-PREFEST is a single-tablet prescription hormone
replacement therapy (HRT) indicated in women with an intact uterus
for the treatment of moderate to severe vasomotor symptoms
associated with menopause, treatment of vulvar and vaginal atrophy,
and prevention of osteoporosis.
Clinical trials tested post-menopausal women and found that
ORTHO-PREFEST was safe and effective in reducing hot-flashes and
providing relief from vaginal atrophy.
The most common side effects in clinical trials over a one-year
period were headache and breast pain. These effects were rarely
serious enough to cause women to discontinue treatment. Other
side-effects experienced by patients during trials included 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).
Estrogens have been associated with increased risks of serious
side-effects including thromboembolic disorders, cardiovascular
disease, and endometrial carcinoma in post-menopausal women.
Do not take this drug (or any estrogens) if you have a known or
suspected pregnancy, breast cancer, or estrogen-dependent
neoplasia. Also, do not take estrogens if you have undiagnosed
abnormal genital bleeding, active thrombophlebitis, or
Women should consult their doctor before beginning hormone
Upon launch, the ORTHO-PREFEST will be co-promoted with Women
First HealthCare, a specialty health care company dedicated to
improving the health of midlife women.
For more information, please contact Nancy Casey of Women First
HealthCare, Inc., 858-509-3814, or visit the Women First
Healthcare, Inc. web site