Label Changes for:
Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)
Changes have been made to the CONTRAINDICATIONS, WARNINGS 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:DETAILED PATIENT LABELING
Venous Thrombosis and Thromboembolism
...Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breast-feed or after a midtrimester pregnancy termination.
Carcinoma of the Reproductive Organs and Breasts
See highlighted text for labeling revisions.