NEW YORK -- December 1, 2008 -- The US Food and Drug Administration (FDA) has approved Synthetic Conjugated Oestrogens-A (SCE-A) 0.625 mg/g Vaginal Cream for the treatment of symptoms related to vulvar and vaginal atrophy including moderate to severe vaginal dryness and pain with intercourse.
The most common side effects in the clinical trials (>3%) were vulvovaginal infections, upper respiratory tract infection, headaches, and hot flashes.
SCE-A Vaginal Cream should not be used in individuals with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of certain cancers; stroke or heart attack in the past year; currently having or having had blood clots or thromboembolic disease including stroke or myocardial infarction; liver problems; allergy to SCE-A Vaginal Cream or any of its ingredients; or known or suspected pregnancy.
The oestrogen-alone substudy of the Women's Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women aged 50 to 79 years during 6.8 years and 7.1 years of treatment with oral conjugated oestrogens (CE) 0.625 mg relative to placebo.
The oestrogen-plus-progestin substudy of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women aged 50 to 79 years during 5.6 years of treatment with oral CE 0.625 mg combined with medroxyprogesterone acetate 2.5 mg per day, relative to placebo.
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of oestrogens. Because of these risks, oestrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
SOURCE: Barr Pharmaceuticals, Inc.
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