Estrogens Increase The Risk of Endometrial Cancer

• Close clinical surveillance of all women taking estrogens is important.

• Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

• There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than "synthetic" estrogens at equivalent estrogen doses.

  Cardiovascular and Other Risks

• Estrogens with or without progestins should not be used for the prevention of cardiovascular disease.

• WHI Study-MI, Stroke, Breast Cancer, PE, DVT:The Women's Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years) during 5 yrs of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (See Package Insert)

  Risk of Probable Dementia

• WHIMS Study: Estrogens Plus Progestins-Dementia:The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during four years of treatment with oral conjugated estrogens combined with medroxyprogresterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See package insert)
  

  Other General Risk Statements

• In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and medroxyprogesterone and other combinations and dosage forms of estrogens and progestins.

• Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals for the individual woman.