Vagifem® (estradiol vaginal tablets) Indications and Usage
Vagifem® is indicated for the treatment of atrophic vaginitis.
Vagifem® Important Safety Information
For additional information about Vagifem® please refer to Prescribing Information, including boxed warning.
ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA.
Three independent, case-controlled studies have reported an increased risk of endometrial cancer in postmenopausal women exposed to exogenous estrogens for more than one year. This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incident rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer-reporting systems, an increase of which may be related to the rapidly expanding use of estrogens during the last decade.
The three case-controlled studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration and treatment and on estrogen dose. In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed, on at least a semiannual basis, to determine the need for continued therapy.
Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or reoccurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy. There is no evidence at present that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equi-estrogenic doses.
Other warnings include: induction of malignant neoplasms, gallbladder disease, effects similar to those caused by estrogen-progestogen oral contraceptives (such as thromoboembolic disease, hepatic adenoma, elevated blood pressure, worsening of glucose tolerance), hypercalcemia, and rarely, trauma induced by the Vagifem® applicator.
In a placebo-controlled clinical trial, the most commonly reported adverse events included: headache (9%), abdominal pain (7%), upper respiratory tract infection (5%), genital moniliasis (5%), and back pain (7%).
The use of Vagifem® is contraindicated in women who exhibit one or more of the following: known or suspected breast carcinoma, known or suspected estrogen-dependent neoplasia, e.g., endometrial carcinoma, abnormal genital bleeding of unknown etiology, known or suspected pregnancy, porphyria, hypersensitivity to any Vagifem® constituents, active thrombophlebitis or thromboembolic disorders, or a past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when used in treatment of breast malignancy).
