Serious Warnings and Precautions The Women’s Health Initiative (WHI) trial is a large clinical study that assessed the benefits and risks of oral combined estrogen plus progestin therapy and oral estrogen- alone therapy compared with placebo (a pill with no active ingredients) in postmenopausal women.
The WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women taking oral combined estrogen plus progestin.
The WHI trial indicated an increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) taking oral estrogen-alone. Therefore, you should highly consider the following: There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.
There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy. Estrogens with or without progestin should not be used for the prevention of heart disease or stroke. Estrogens with or without progestin should be used at the lowest effective dose and for the shortest period of time possible.
Regular medical follow-up is advised. Breast Cancer The results of WHI trial indicated an increased risk of breast cancer in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo. The results of the WHI trial indicated no difference in the risk of breast cancer in post- menopausal women with prior hysterectomy taking estrogen alone compared to women taking placebo.
Estrogens with or without progestin should not be taken by women who have a personal history of breast cancer. In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies, or abnormal mammograms (breast x-rays) should consult with their doctor before starting HRT.
28 Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor. Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women.
You should review technique for breast self-examination with your doctor. Overgrowth of the lining of the uterus and cancer of the uterus The use of estrogen-alone therapy by post menopausal women who still have a uterus increases the risk of endometrial hyperplasia (overgrowth of the lining of the uterus) which increases the risk of endometrial cancer (cancer of the lining of the uterus).
If you still have your uterus, you should take a progestin medication (another hormone drug) regularly for a certain number of days of each month to reduce the risk of endometrial hyperplasia. You should discuss progestin therapy and risk factors for endometrial hyperplasia and endometrial carcinoma with your doctor.
You should also report any unexpected or unusual vaginal bleeding to your doctor. If you have your uterus removed, you are not at risk of endometrial hyperplasia or endometrial carcinoma. Progestin therapy is therefore not generally required in women who have had a hysterectomy.
Ovarian cancer In some studies, the use of estrogen-alone and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer. Heart Disease and Stroke The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.
The results of the WHI trial indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo. Abnormal Blood Clotting The results of the WHI trial indicated an increased risk of blood clots in the lungs and large veins in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.
The results of the WHI trial indicated an increased risk of blood clots in the large veins but no difference in the risk of blood clots in the lungs in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.
29 The risk of blood clots also increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery.
You should discuss risk factors for blood clots with your doctor since blood clots can be life-threatening or cause serious disability. Gallbladder Disease The use of estrogens by postmenopausal women has been associated with an increased risk of gallbladder disease requiring surgery.
Dementia The Women’s Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial and indicated an increased risk of dementia (loss of memory and intellectual function) in post-menopausal women age 65 and over taking oral combined estrogen plus progestin compared to women taking placebo.
The WHIMS indicated no difference in the risk of dementia in post-menopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo. BEFORE you use Estragyn Vaginal Cream talk to your doctor or pharmacist if you: Have a history of allergy or intolerance to any medications or other substances Have a personal history of breast disease (including breast lumps) and/or breast biopsies or a family history of breast cancer.
Have experienced any unusual or undiagnosed vaginal bleeding Have a history of uterine fibroids or endometriosis Have a history of liver disease, liver tumours, or jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or […]