Premarin (conjugated estrogens) Vaginal Cream
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.|
Summary of Changes to Contraindications and Warnings
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
PATIENT COUNSELING INFORMATION (new subsection)
PATIENT PACKAGE INSERT
(See highlighted label for specific changes.)
WARNING: ENDOMETRIAL CANCER,
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.3)].
Premarin Vaginal Cream therapy should not be used in women with any of the following conditions:
...Active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of these conditions...
WARNINGS AND PRECAUTIONS
...Should a stroke occur or be suspected, estrogens should be discontinued immediately...
...Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg) versus those receiving placebo (18 versus 21 per 10,000 women-years)...
Coronary Heart Disease
...Subgroup analyses of women 50 to 59 years of age suggest a statistically non-significant reduction in CHD events (CE 0.625 mg compared to placebo) in women with less than 10 years since
Venous Thromboembolism (VTE)
...Should a VTE occur or be suspected, estrogens should be discontinued immediately...
...In a 52-week clinical trial using Premarin Vaginal Cream alone (0.5 g inserted twice weekly or daily for 21 days, then off for 7 days), there was no evidence of endometrial hyperplasia or
Addition of a Progestin When a Woman Has Not Had a Hysterectomy:
...There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone
Estrogens should be used with caution in individuals with hypoparathyroidism as estrogen-induced hypocalcemia may occur.