"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.
There is no specific antidote for OSPHENA.
OSPHENA is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding
- Known or suspected estrogen-dependent neoplasia
- Active DVT, pulmonary embolism (PE), or a history of these conditions
- Active arterial thromboembolic disease [for example, stroke and myocardial infarctions (MI)], or a history of these conditions
- OSPHENA is contraindicated in women who are or may become pregnant. OSPHENA may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m². If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.
Last reviewed on RxList: 3/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Osphena Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.