IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION & INDICATIONS
Do not take additional estrogens, progestins, or estrogen agonists/antagonists while taking DUAVEE™ (conjugated estrogens/bazedoxifene).
Using estrogen may increase your chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while taking DUAVEE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. A healthcare provider should check unusual vaginal bleeding to find the cause.
Do not use estrogens to prevent heart disease, heart attacks, strokes, or dementia.
Estrogens may increase the chance of getting blood clots or strokes.
Using estrogens may increase the chance of getting dementia, based on a study of women 65 years of age or older.
You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.
Do not use DUAVEE if you: have or had blood clots; are allergic to any of its ingredients; have unusual vaginal bleeding; have or had certain cancers (eg, uterine or breast), liver problems, or bleeding disorders; or are pregnant, may become pregnant, or are breastfeeding a baby.
The use of estrogen alone has been reported to result in an increase in abnormal mammograms requiring further evaluation. The effect of treatment with DUAVEE on the risk of breast and ovarian cancer is unknown.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss of vision, pancreatitis, or liver problems occur. If you take thyroid medication, consult your healthcare provider as use of estrogens may change the amount needed.
The most common side effects include muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain.
DUAVEE is used after menopause for women with a uterus to reduce moderate-to-severe hot flashes and to help reduce the chances of developing osteoporosis.
If you use DUAVEE only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. DUAVEE should be taken for the shortest time possible and only for as long as treatment is needed. You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.