ADVERSE REACTIONS See BOXED WARNINGS, WARNINGS, andPRECAUTIONS. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. During the first year of a 2-year clinical trial with 2333 postmenopausal women between 40 and 65 years of age (88% Caucasian), 1012 women were treated with conjugated estrogens and 332 were treated with placebo. Table 5 summarizes adverse events that occurred at a rate of 5%.    The following additional adverse reactions have been reported with estrogen and/ or progestin therapy: 1. Genitourinary system Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea Increase in size of uterine leiomyomata Vaginitis, including vaginal candidiasis Change in amount of cervical secretion Change in cervical ectropion Ovarian cancer Endometrial hyperplasia Endometrial cancer 2. Breasts Tenderness, enlargement, pain, discharge, galactorrhea Fibrocystic breast changes Breast cancer 3. Cardiovascular Deep and superficial venous thrombosis Pulmonary embolism Thrombophlebitis Myocardial infarction Stroke Increase in blood pressure 4. Gastrointestinal Nausea, vomiting Abdominal cramps, bloating Cholestatic jaundice Increased incidence of gallbladder disease Pancreatitis Enlargement of hepatic hemangiomas | ||||
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