"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Estrogens should not be used in individuals with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known or suspected cancer of the breast.
- Known or suspected estrogen-dependent neoplasia.
- Active deep vein thrombosis, pulmonary embolism or history of these conditions.
- Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
- Liver dysfunction or disease.
- DEPO-Estradiol (estradiol cypionate injection) should not be used in patients with known hypersensitivity to its ingredients.
- Known or suspected pregnancy. There is no indication for DEPO-Estradiol (estradiol cypionate injection) in pregnancy.
There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS.)This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/25/2009
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