"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.
Vivelle-Dot® (estradiol transdermal system) 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-dependent neoplasia.
- Active deep vein thrombosis, pulmonary embolism or a 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.
- Vivelle-Dot (estradiol transdermal system) should not be used in patients with known hypersensitivity to its ingredients.
- Known or suspected pregnancy. There is no indication for Vivelle-Dot (estradiol transdermal system) 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).
Last reviewed on RxList: 5/8/2008
Additional Vivelle-Dot Information
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