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FDA Approved Treatment for Painful Intercourse (Dyspareunia) Due to Menopause
Date:2/27/2013

had cerebral thromboembolic and hemorrhagic stroke incidence rates of 0.72 and 1.45 per thousand women vs. 1.04 and 0 per thousand women for placebo and a DVT incidence rate of 1.45 vs. 1.04 per thousand women for placebo. Osphena should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

Contraindications

  •     Undiagnosed abnormal genital bleeding
  •     Known or suspected estrogen-dependent neoplasia
  •     Active deep vein thrombosis (DVT), pulmonary embolism (PE) or a history of these conditions
  •     Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions
  •     In women who are or may become pregnant, as Osphena may cause fetal harm

Warnings and Precautions

Cardiovascular Disorders: In the WHI estrogen-alone substudy, a statistically significant increased risk of stroke was reported in postmenopausal women (50 to 79 years of age) receiving CE 0.625 mg per day relative to placebo (45 vs. 33 per 10,000 women-years). The increase in risk was demonstrated in year 1 and persisted. In Osphena clinical trials of up to 15 months the incidence rates compared to placebo for cerebral thromboembolic and hemorrhagic stroke were 0.72 Osphena 60 mg vs. 1.04 placebo and 1.45 Osphena 60 mg vs. 0 placebo per thousand women. Should thromboembolic or hemorrhagic stroke occur or be suspected, Osphena should be discontinued immediately.

Coronary Heart Disease: In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) was reported in women receiving estrogen-alone compared to placebo. In clinical trials, a single MI occurred in a woman receiving Osphena 60 mg.

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