Label Changes for:
EstroGel 0.06% (estradiol gel)
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 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.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
PATIENT PACKAGE INSERT
Cardiovascular and Other Risks
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia...
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo...
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins...
See highlighted text for labeling revisions.