"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.
PREMARIN therapy should not be used in individuals with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer except in appropriately selected patients being treated for metastatic disease.
- Known or suspected estrogen-dependent neoplasia.
- Active DVT, PE, or a history of these conditions.
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
- Known anaphylactic reaction or angioedema to PREMARIN tablets.
- Known liver dysfunction or disease.
- Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.
- Known or suspected pregnancy.
Last reviewed on RxList: 11/11/2011
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