"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.
OGEN (estropipate) should not be used in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of cancer of the breast.
- Known or suspected estrogen (estropipate) -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.
- OGEN (estropipate) should not be used in patients with known hypersensitivity to its ingredients.
- Known or suspected pregnancy. There is no indication for OGEN (estropipate) in pregnancy.
There appears to be little or no increased risk of birth defects in children born to women who have used estrogen (estropipate) s 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: 4/30/2009
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